Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma: a randomised comparative multicentre phase II study (STEREOPAC)

2022-501181-22-01 Protocol STEREOPAC-001 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 6 Feb 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 18 sites · Protocol STEREOPAC-001

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 256
Countries 1
Sites 18

Pancreatic adenocarcinoma

The primary objective is to compare R0 resection (> 1 mm) and DFS (as co-primary endpoint) in arm A (‘standard’-chemotherapy) to arm B (‘experimental’-chemotherapy + SBRT) in an intention-to-treat analysis.

Key facts

Sponsor
Hopital Erasme
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
6 Feb 2023 → ongoing
Decision date (initial)
2022-11-09
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Rising Tide · Anticancer Fund

External identifiers

EU CT number
2022-501181-22-01
ClinicalTrials.gov
NCT05083247

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

The primary objective is to compare R0 resection (> 1 mm) and DFS (as co-primary endpoint) in arm A (‘standard’-chemotherapy) to arm B (‘experimental’-chemotherapy + SBRT) in an intention-to-treat analysis.

Secondary objectives 10

  1. Resection rate
  2. Overall Survival
  3. Locoregional failure free interval
  4. Distant metastases free interval
  5. Complete feasibility of the therapeutic sequence
  6. Pathologic complete response rate
  7. Toxicity (early and late)
  8. Postoperative complications rate
  9. Quality of life (QoL) assessment
  10. Technical and quality success rate of EUS-delivered fiducials

Conditions and MedDRA coding

Pancreatic adenocarcinoma

Regulatory references

Plan to share IPD
Yes
IPD plan description
In line with the EU data sharing policy, individual subject-level data will be shared with the scientific community (either as anonymised or pseudonymised data sets), while maintaining the integrity and privacy of the trial participants and in compliance with the EU General Data Protection Regulation (GDPR) and national or local rules. Data and other trial documents should be made available through an appropriate data repository, helping to ensure that the data objects are properly prepared, are available in the longer term, are stored securely and subject to rigorous governance. The terms and conditions of data transfers to a repository and the data sharing process shall be subject to specific data processing agreements to be established between the concerned parties as well as to a specific data sharing plan, where the details are specified
EU CT numberTitleSponsor
2022-501181-22-00 Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma: a randomised comparative multicentre phase II study (STEREOPAC) Hopital Erasme

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process , body or tail. Diagnosis should be verified by local pathologist.
  2. cTNM stage: T1-4 N0-2 M0
  3. Confirmation of clinical and radiographic stage as borderline resectable determined centrally by review of a diagnostic multisliced triphasic CT scan and/or MRI with contrast by a multidisciplinary board composed of a dedicated oncological surgeon, radiologist and GI oncologist
  4. No prior chemotherapy or radiation for pancreatic cancer unless the neoadjuvant regimen as described
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. No grade ≥ 2 neuropathies
  7. Laboratory parameters as follows: Absolute neutrophil count (ANC) ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 9 g/dL, Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR > 45 mL/min, Bilirubin ≤ 1.5 x ULN including after adequate biliary stenting with metal stent (ideally 4 cm length), Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5x ULN, CA 19.9 < 2500 kU/l (baseline and absence of cholestasis)

Exclusion criteria 11

  1. Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI, or PET scan), or laparoscopy, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases
  2. Unresectable disease as defined by the NCCN criteria, ie > 180° arterial encasement (SMA), unreconstructible or fully thrombosed venous invasion
  3. CA 19.9 > 2500 kU/l (baseline, prior neoadjuvant therapy and absence of cholestasis)
  4. Contraindication of surgery (general)
  5. Contraindications to receive mFFX or Gem-Nab-P
  6. History of radiotherapy of the upper abdomen
  7. Prior treatment with oxaliplatin, irinotecan, 5-FU or capecitabin for PDAC
  8. Complete DPD deficiency (patients with complete DPD deficiency can be included and started on Gem-Nab if all other inclusion and exclusion criteria are met)
  9. Major surgery within 4 weeks of study entry
  10. Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social / psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form
  11. Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to inclusion in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Residual tumour (R)0 resection
  2. Disease-free-survival

Secondary endpoints 10

  1. Resection rate
  2. Locoregional failure free interval
  3. Distant metastases free interval
  4. Toxicity, Incidence of adverse events
  5. Complete feasibility of the therapeutic sequence
  6. Overall survival
  7. Pathologic complete/major response rate (pCR)
  8. Quality of life assessment
  9. Postoperative complications rate
  10. Technical and quality success rate of EUS-delivered fiducials

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 33

Folinic Acid

SUB13910MIG · Substance

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anhydrous Calcium Folinate

SCP26549405 · ATC

Active substance
Anhydrous Calcium Folinate
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Folinate EG 100mg/10ml oplossing voor injectie

PRD455340 · Product

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
BE250311
MA holder
EUROGENERICS N.V./S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Folinate EG 100mg/10ml oplossing voor injectie

PRD933651 · Product

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
BE250336
MA holder
EUROGENERICS N.V./S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Folinate EG 100mg/10ml oplossing voor injectie

PRD460786 · Product

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
BE250327
MA holder
EUROGENERICS N.V./S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Folinate EG 100mg/10ml oplossing voor injectie

PRD933650 · Product

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
BE250345
MA holder
EUROGENERICS N.V./S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie

PRD386319 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
BE373992
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SCP1891954 · ATC

Active substance
Oxaliplatin
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie

PRD386321 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
BE418555
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie

PRD386320 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
BE374001
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan AB 20 mg/ml solution à diluer pour perfusion

PRD9261828 · Product

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CE02 — -
Marketing authorisation
BE316994
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan AB 20 mg/ml solution à diluer pour perfusion

PRD9261825 · Product

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CE02 — -
Marketing authorisation
BE384657
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan Hydrochloride Trihydrate

SUB45873 · Substance

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan AB 20 mg/ml solution à diluer pour perfusion

PRD9261826 · Product

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CE02 — -
Marketing authorisation
BE333121
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan

SCP14385744 · ATC

Active substance
Irinotecan
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01XX19 — IRINOTECAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan AB 20 mg/ml solution à diluer pour perfusion

PRD9261827 · Product

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
165 mg/m2 milligram(s)/sq. meter
Max total dose
1320 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CE02 — -
Marketing authorisation
BE317003
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine AB 40 mg/ml, concentraat voor oplossing voor infusie

PRD4171258 · Product

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
12000 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
BE489795
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine AB 40 mg/ml, concentraat voor oplossing voor infusie

PRD4171259 · Product

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
12000 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
BE489777
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SUB07892MIG · Substance

Active substance
Gemcitabine
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
12000 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SCP1686259 · ATC

Active substance
Gemcitabine
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
12000 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine AB 40 mg/ml, concentraat voor oplossing voor infusie

PRD4171251 · Product

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
12000 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
BE489786
MA holder
AUROBINDO N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Abraxane 5 mg/ml powder for dispersion for infusion.

PRD9254301 · Product

Active substance
Paclitaxel Albumin-Bound
Substance synonyms
PACLITAXEL ALBUMINE-BOUND
Pharmaceutical form
DISPERSION FOR INFUSION
Route of administration
INFUSION
Max daily dose
125 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
EU/1/07/428/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SCP247399 · ATC

Active substance
Paclitaxel
Substance synonyms
ONCOGEL, ABI-007, MBT 0206
Route of administration
INFUSION
Max daily dose
125 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
POWDER FOR SUSPENSION FOR SOLUTION
Route of administration
INFUSION
Max daily dose
125 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Abraxane 5 mg/ml powder for dispersion for infusion.

PRD9254303 · Product

Active substance
Paclitaxel Albumin-Bound
Substance synonyms
PACLITAXEL ALBUMINE-BOUND
Pharmaceutical form
DISPERSION FOR INFUSION
Route of administration
INFUSION
Max daily dose
125 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
EU/1/07/428/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SCP7587892 · ATC

Active substance
Fluorouracil
Substance synonyms
5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

PRD415450 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
BE415712
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

PRD415453 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
BE345597
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

PRD415452 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
BE345624
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

PRD415451 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
BE345606
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

PRD415449 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
BE345615
MA holder
ACCORD HEALTHCARE B.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hopital Erasme

4 Total trials 3 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Hopital Erasme
Address
Lennikse Baan 808
City
Anderlecht
Postcode
1070
Country
Belgium

Scientific contact point

Organisation
Hopital Erasme
Contact name
Jean-Luc Van Laethem

Public contact point

Organisation
Hopital Erasme
Contact name
Mia Persoons

Third parties 1

OrganisationCity, countryDuties
Groupe Belge D'Oncologie Digestive
ORG-100042636
 Zaventem, Belgium On site monitoring, Code 12, Code 2, Code 5, Data management, Code 8

Locations

1 EU/EEA country · 18 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 256 18
Rest of world — 0 —

Investigational sites

Belgium

18 sites · Ongoing, recruiting
Algemeen Ziekenhuis Delta
Gastroenterology and Hepatology, Deltalaan 1, 8800, Roeselare
Hopital Erasme
Department of Gastroenterology, Hepato-Pancreatology and Digestive Oncology, Lennikse Baan 808, 1070, Anderlecht
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
CHU Ambroise Pare
Oncology, Boulevard President Kennedy 2, 7000, Mons
Pole Hospitalier Jolimont
Gastroenterology, Rue Ferrer 159, 7100, La Louviere
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncologie médicale, Place Louise Godin 15, 5000, Namur
Clinical Saint-Luc Bouge
Oncology, Rue Saint-Luc 8, 5004, Namur
Algemeen Ziekenhuis Groeninge
Maag-Darm-Leverziekten, President Kennedylaan 4, 8500, Kortrijk
UCL Mont-Godinne
Oncology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
CHC MontLegia
Gastroenterology, Boulev. De Patience Et Beajonc 2, 4000, Liege
UZ Brussel
Hepatopancreatobiliary Surgery, Laarbeeklaan 101, 1090, Jette
Cliniques Universitaires Saint-Luc
Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az St-Jan Brugge-Oostende A.V.
Maag-, Darm- en leverziekten, Ruddershove 10, 8000, Brugge
Ziekenhuis Aan De Stroom
Radiation Oncology, Oosterveldlaan 24, 2610, Antwerp
Chirec
Gastroenterology, Boulevard Du Triomphe 201, 1160, Brussels
CHU De Liege
Radiotherapy department, Avenue De L'hopital 1, 4000, Liege
Institut Jules Bordet
Radiation oncology, Mijlenmeersstraat 90, 1070, Brussels
Antwerp University Hospital
Oncology/Gastroenterology, Drie Eikenstraat 655, 2650, Edegem

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-02-06 2023-03-24

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol STEREOPAC_2022-501181-22-01 - Tracked changes - redacted 2.1
Protocol (for publication) D1_protocol_FAPI PANC-2022-501181-22-01 -summary of changes 2.0
Protocol (for publication) D1_protocol_FAPI-PANC-2022-501181-22-01 2.0
Protocol (for publication) D1_protocol_FAPI-PANC-2022-501181-22-01 - TC 2.0
Protocol (for publication) D1_Protocol_STEREOPAC 2022-501181-22-01 - redacted 2.1
Protocol (for publication) D1_Protocol_STEREOPAC 2022-501181-22-01- SOC 2.0 &amp; 2.1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 1
Subject information and informed consent form (for publication) L1_ICF Biological study Dutch 2.0
Subject information and informed consent form (for publication) L1_ICF Biological study English 2.0
Subject information and informed consent form (for publication) L1_ICF Biological study French 2.0
Subject information and informed consent form (for publication) L1_ICF Main study Dutch 2.0
Subject information and informed consent form (for publication) L1_ICF Main study English 2.0
Subject information and informed consent form (for publication) L1_ICF Main study French 2.0
Subject information and informed consent form (for publication) L1_ICF_Biological study ENG -Tracked changes 2.0
Subject information and informed consent form (for publication) L1_ICF_Biological study FR -Tracked changes 2.0
Subject information and informed consent form (for publication) L1_ICF_Biological study NL -Tracked changes 2.0
Subject information and informed consent form (for publication) L1_ICF_FAPI-PANC_Main Dutch 2.0
Subject information and informed consent form (for publication) L1_ICF_FAPI-PANC_Main Dutch TC 2.0
Subject information and informed consent form (for publication) L1_ICF_FAPI-PANC_Main French 2.0
Subject information and informed consent form (for publication) L1_ICF_FAPI-PANC_Main French TC 2.0
Subject information and informed consent form (for publication) L1_ICF_Main study ENG - Tracked changes 2.0
Subject information and informed consent form (for publication) L1_ICF_Main study FR-Tracked changes 2.0
Subject information and informed consent form (for publication) L1_ICF_Main study NL - Tracked changes 2.0
Subject information and informed consent form (for publication) L2_patient experiences questionnaire Dutch 1.0
Subject information and informed consent form (for publication) L2_patient experiences questionnaire French 1.0
Subject information and informed consent form (for publication) L2_Questionnaire PAN26 Dutch 1
Subject information and informed consent form (for publication) L2_Questionnaire PAN26 English 1
Subject information and informed consent form (for publication) L2_Questionnaire PAN26 French 1
Subject information and informed consent form (for publication) L2_Questionnaire PHQ-9 Dutch 1
Subject information and informed consent form (for publication) L2_Questionnaire PHQ-9 English 1
Subject information and informed consent form (for publication) L2_Questionnaire PHQ-9 French 1
Subject information and informed consent form (for publication) L2_Questionnaire QLQ-C30 Dutch 1
Subject information and informed consent form (for publication) L2_Questionnaire QLQ-C30 English 1
Subject information and informed consent form (for publication) L2_Questionnaire QLQ-C30 French 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Abraxane FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Abraxane NL 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Fluorouracil FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Fluorouracil NL 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Folinate FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Folinate NL 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Gemcitabine FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Gemcitabine NL 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Irinotecan FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Irinotecan NL 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Oxaliplatine FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Oxaliplatine NL 1
Synopsis of the protocol (for publication) D1_2022-501181-22-00 STEREOPAC Protocol Synopsis FR 1.1
Synopsis of the protocol (for publication) D1_2022-501181-22-00 STEREOPAC Protocol Synopsis GE 1.1
Synopsis of the protocol (for publication) D1_2022-501181-22-00 STEREOPAC Protocol Synopsis NL 1.1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-08-10 Belgium Acceptable
2022-11-08
 2022-11-09
2 SUBSTANTIAL MODIFICATION SM-1 2023-09-28 Belgium Acceptable
2024-01-10
 2024-01-10
3 SUBSTANTIAL MODIFICATION SM-2 2026-01-30 Belgium Acceptable
2026-04-01
 2026-04-01
4 SUBSTANTIAL MODIFICATION SM-4 2026-04-24 Belgium Acceptable 2026-05-26

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