Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
124
Countries
1
Sites
7
Rectum cancer
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery
Key facts
- Sponsor
- Region Sjaelland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 14 Nov 2016 → ongoing
- Decision date (initial)
- 2024-10-08
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517748-76-00
- EudraCT number
- 2016-004057-33
- ClinicalTrials.gov
- NCT03280407
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery
Secondary objectives 1
- Early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided. Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.
Conditions and MedDRA coding
Rectum cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge. Locally advanced tumor based on imaging (Tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to DCCG guidelines, T3c or T4 tumors 10-15 cm from the anal verge). Deemed resectable at the multidisciplinary team (MDT) conference. ECOG performance status 0-2. Age at least 18 years. Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l., Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, Calculated or measured renal glomerular filtration rate at least 30 mL/min). Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable. Written and orally informed consent
Exclusion criteria 1
- • Distant metastasis • Invasive ingrowth into other organs • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy • Previous radiotherapy to the pelvis • Previous treatment with 5FU or oxaliplatin • Surgery within two weeks • Neuropathy NCI grade > 1 • Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri • Pregnant (positive pregnancy test) or breast feeding women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease free survival
Secondary endpoints 1
- • Overall survival • Local and distant relapse • Early and late toxicity • Functional outcome and QoL • Resection rate • Postoperative morbidity • Postoperative mortality • Rate of downsizing • Tumor regression grade • Translational research
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
5-FU medac 50 mg/ml, Injektionslösung
PRD536079 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 41196.00.00
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin 5mg/ml concentrate for Solution for Infusion
PRD386278 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- PL 20075/0112
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Capecitabine Glenmark 150 mg film-coated tablets
PRD10562679 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- 27817
- MA holder
- GLENMARK PHARMACEUTICALS S.R.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Capecitabine Glenmark 500 mg filmomhulde tabletten
PRD10352476 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- RVG 130924
- MA holder
- GLENMARK ARZNEIMITTEL GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Leucovorin 10 mg/ml Lösung zur Injektion/ Infusion
PRD4259228 · Product
- Active substance
- Calcium Folinate Pentahydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 15034.00.00
- MA holder
- PFIZER PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Capecitabine Pharmacare 150 mg film-coated tablets
PRD10891518 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- MA1033/01801
- MA holder
- PHARMACARE PREMIUM LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Capecitabine Accord 500 mg film-coated tablets
PRD3441392 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- EU/1/12/762/013
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Sjaelland
- Sponsor organisation
- Region Sjaelland
- Address
- Lykkebaekvej 1
- City
- Koege
- Postcode
- 4600
- Country
- Denmark
Scientific contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Public contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| University of Southern Denmark ORG-100031250
|
Odense M, Denmark | On site monitoring |
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 124 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Region Hovedstaden
Department of Oncology, Borgmester Ib Juuls Vej 31, 2730, Herlev
Region Syddanmark
Department of Oncology, J.B. Winsloews Vej 18, 5000, Odense C
Region Syddanmark
Vejle Sygehus, Lille Grundet Hulvej 25, 7100, Vejle
Region Midtjylland
Department of Surgery, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Sjaelland
Department of Surgery, Lykkebaekvej 1, 4600, Koege
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Nordjylland
Department of Oncology, Moelleparkvej 10, 9000, Aalborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2016-11-14 | 2017-03-01 | 2024-07-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | NEOLAR protocol | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinf version 2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Calciumfolinat injektionsvske oplsning 10 mg ml | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Capecitabin Stada filmovertrukne tabletter 150 mg og 500 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Capecitabin Stada filmovertrukne tabletter 150 mg og 500 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluorouracil Pfizer injektionsvske oplsning 50 mg ml | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Oxaliplatin Sandoz koncentrat til infusionsvske oplsning 5 mg ml | 1 |
| Synopsis of the protocol (for publication) | Protokolsynopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-17 | Denmark | Acceptable 2024-10-02
|
2024-10-08 |