Nordic Pancreatic Cancer Trial (NORPACT) – 1

2024-517719-65-00 Protocol NORPACT-1 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 1 Feb 2017 · Status Ongoing, recruiting · 2 EU/EEA countries · 10 sites · Protocol NORPACT-1

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 131
Countries 2
Sites 10

Resectable pancreatic head cancer

The aim of this study is to assess the additional value of neoadjuvant chemotherapy to the standard treatment (surgery + adjuvant chemotherapy) for resectable cancer of the pancreatic head as a means of avoiding early mortality and improve overall survival.

Key facts

Sponsor
Oslo University Hospital HF
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
1 Feb 2017 → ongoing
Decision date (initial)
2024-11-12
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-517719-65-00
EudraCT number
2015-001635-21
ClinicalTrials.gov
NCT02919787

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

The aim of this study is to assess the additional value of neoadjuvant chemotherapy to the standard treatment (surgery + adjuvant chemotherapy) for resectable cancer of the pancreatic head as a means of avoiding early mortality and improve overall survival.

Conditions and MedDRA coding

Resectable pancreatic head cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Resectable tumour of the pancreatic head radiologically strongly suspect of pancreatic adenocarcinoma
  2. T1-3, Nx, M0 (UICC 7th version, 2010)
  3. Age > 18 year and considered fit for major surgery
  4. Written informed consent
  5. Considered able to receive the study specific chemotherapy

Exclusion criteria 13

  1. Co-morbidity precluding pancreatoduodenectomy
  2. Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
  3. Chronic neuropathy ≥ grade 2
  4. WHO performance score ≥ 2
  5. Granulocyte count < 1500 per cubic millimetre (< 1,5 x 109/L)
  6. Platelet count < 100 000 per cubic millimetre (< 100 x 109/L)
  7. Serum creatinine > 1.5 UNL (upper limit normal range)
  8. Albumin < 2,5 g/dl (< 25 g/L)
  9. Female patients in child bearing age not using adequate contraception, pregnant or lactating women
  10. Mental or organic disorders which could interfere with informed consent or treatments
  11. Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
  12. Percutaneous tumor biopsy
  13. Any reason why, in the opinion of the investigator, the patient should not participate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival at 18 months after the date of randomisation

Secondary endpoints 10

  1. Progression-free survival assessed at both 18 months and as time since randomisation,
  2. Overall mortality at 1 year after commencement of allocated treatment for patients who ultimately underwent resection
  3. Overall survival in both the intention-to-treat (ITT) and per-protocol populations
  4. Overall survival and overall survival following resection
  5. Histopathological response (R0 resection and [y]pN0 disease)
  6. Compliication rates at 90 days after surgery
  7. Feasibility of neoadjuvant and adjuvant chemotherapy (as assessed by adverse events, dose reductions, and dose delays),
  8. Completion rates of all parts of multimodal treatment
  9. Health economics
  10. Quality of life

Investigational products

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

Test 6

Gemcitabine Hydrochloride

SCP1128788 · ATC

Active substance
Gemcitabine Hydrochloride
Substance synonyms
GEMCITABINE (AS HYDROCHLORIDE), 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
Route of administration
INFUSION
Max daily dose
2200 mg milligram(s)
Max total dose
39600 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SCP1165178 · 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
5280 mg milligram(s)
Max total dose
63360 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Capecitabine

SCP131876 · ATC

Active substance
Capecitabine
Route of administration
ORAL
Max daily dose
3652 mg milligram(s)
Max total dose
460152 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
L01BC06 — CAPECITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan Hydrochloride

SCP105621456 · ATC

Active substance
Irinotecan Hydrochloride
Route of administration
INFUSION
Max daily dose
330 mg milligram(s)
Max total dose
3960 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
L01CE02 — IRINOTECAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SCP128961 · ATC

Active substance
Oxaliplatin
Route of administration
INFUSION
Max daily dose
187.5 mg milligram(s)
Max total dose
2244 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Calcium Folinate

SCP107133400 · ATC

Active substance
Calcium Folinate
Substance synonyms
LEUCOVORIN CALCIUM
Route of administration
INFUSION
Max daily dose
880 mg milligram(s)
Max total dose
10560 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

73 Total trials 37 Recruiting 25 Ended
Academic / Non-commercial
Sponsor organisation
Oslo University Hospital HF
Address
Taarnbygget, Kirkeveien 166 Kirkeveien 166
City
Oslo
Postcode
0450
Country
Norway

Scientific contact point

Organisation
Oslo University Hospital HF
Contact name
Knut Jørgen Labori

Public contact point

Organisation
Oslo University Hospital HF
Contact name
Knut Jørgen Labori

Locations

2 EU/EEA countries · 10 investigational sites

By country

CountryMS statusPlanned subjectsSites
Norway Ongoing, recruiting 60 5
Sweden Ongoing, recruiting 71 5
Rest of world — 0 —

Investigational sites

Norway

5 sites · Ongoing, recruiting
Haukeland University Hospital
Department of Gastrointestinal Surgery, Haukelandsveien 22, 5009, Bergen
Oslo University Hospital HF
Department of Hepato Pancreato Biliary Surgery, Taarnbygget, Kirkeveien 166, Oslo
Universitetssykehuset Nord-Norge HF
Department of Gastrointestinal Surgery, P. O. Box 100, 9038, Tromsoe
St. Olavs Hospital HF
Department of Gastrointestinal Surgery, P. O. Box 3250, Torgarden, Trondheim
Helse Stavanger HF
Department of Gastrointestinal Surgery, P. O. Box 8100, 4068, Stavanger

Sweden

5 sites · Ongoing, recruiting
University of Gothenburg and Sahlgrenska University Hospital (SU)
Department of Surgery, Diagnosvägen 21, 41650, Gothenburg
Skåne University Hospital
Department of Clinical Sciences Lund, Surgery, Östra Varvsgatan 11 G, Sweden, Malmo
Karolinska University Hospital
Division of Surgery and Oncology, Department of Clinical Science, Halsovagen, Flemingsberg, Huddinge
Norrlands Universitetssjukhus
Department of Surgical and Perioperative Sciences, Surgery, Norrlands Universitetssjukhus Umeå, 901 85, Umeå
Linkopings Universitet
Department of Surgery and Department of Biomedical and Clinical Sciences, Sandbacksgatan 7, Linkopings Domkyrkofors., Linkoping

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Norway 2017-02-01 2017-02-01
Sweden 2017-02-01 2017-02-01

Results and documents

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

Documents 17 files

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

TypeTitleVersion
Protocol (for publication) D1_ Protocol EU CT 2024-517719-65-00 8
Recruitment arrangements (for publication) Placeholder 1
Recruitment arrangements (for publication) Placeholder 1
Subject information and informed consent form (for publication) L1_SIS and ICF 4
Subject information and informed consent form (for publication) L1_SIS and ICF 2
Summary of Product Characteristics (SmPC) (for publication) Capecitabine_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Capecitabine_Sweden 1
Summary of Product Characteristics (SmPC) (for publication) Fluorouracil_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Fluorouracil_Sverige 1
Summary of Product Characteristics (SmPC) (for publication) Folinic acid_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Folinic acid_Sweden 1
Summary of Product Characteristics (SmPC) (for publication) Gemcitabine _Sweden 1
Summary of Product Characteristics (SmPC) (for publication) Gemcitabine_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Irinotecan_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Irinotecan_Sweden 1
Summary of Product Characteristics (SmPC) (for publication) Oxaliplatin_Norway 1
Summary of Product Characteristics (SmPC) (for publication) Oxaliplatin_Sweden 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-09 Norway Acceptable
2024-11-11
 2024-11-11

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