Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
247
Countries
2
Sites
7
Colon cancer
To investigate the effect of neoadjuvant chemotherapy in locally advanced colon cancer as estimated by disease free survival.
Key facts
- Sponsor
- Lillebaelt Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Oct 2013 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514294-22-01
- EudraCT number
- 2013-002363-26
- ClinicalTrials.gov
- NCT01918527
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To investigate the effect of neoadjuvant chemotherapy in locally advanced colon cancer as estimated by disease free survival.
Conditions and MedDRA coding
Colon cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514294-22-00 | Neoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer (NeoCol) | Lillebaelt Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan. • Age ≥ 18 years • PS 0-2. • Hematology ANC ≥1.5x109/l. Thrombocytes ≥ 100x109/l. • Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value • Consent to translational research • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. • Written and orally informed consent.
Exclusion criteria 1
- • Patients with distant metastases. • Acute operation • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion. • Active, serious infection or other serious disease. • Peripheral neuropathy NCI grade > 1 • Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri. • Other investigational treatment within 30 days prior to treatment start. • Hypersensitivity to one or more of the active or auxiliary substances.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Two-year disease free survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 224000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRACAVERNOUS USE
- Max daily dose
- 130 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1040 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lillebaelt Hospital
- Sponsor organisation
- Lillebaelt Hospital
- Address
- Beriderbakken 4
- City
- Vejle
- Postcode
- 7100
- Country
- Denmark
Scientific contact point
- Organisation
- Lillebaelt Hospital
- Contact name
- Lars Henrik Jensen
Public contact point
- Organisation
- Lillebaelt Hospital
- Contact name
- Lars Henrik Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| University of Southern Denmark ORG-100031250
|
Odense C, Denmark | On site monitoring |
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 193 | 6 |
| Norway | Ongoing, recruitment ended | 54 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Sygehus Soenderjylland Soenderborg
Department of Oncology, Sydvang 1, 6400, Soenderborg
Aalborg University Hospital
Department of Oncology, Hobrovej 18-22, 9000, Aalborg
Region Hovedstaden
Department of Oncology, Borgmester Ib Juuls Vej 31, 2730, Herlev
Lillebaelt Hospital
Department of Oncology, Beriderbakken 4, 7100, Vejle
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Nordsjællands Hospital
Department of Oncology, Dyrehavevej 29, 3400, Hillerød
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 | 2013-10-14 | 2013-10-14 | 2020-12-03 | ||
| Norway | 2015-02-11 | 2015-02-11 | 2020-12-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU2013-002363-26 | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF all | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_N | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC capecitabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC oxaliplatin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-27 | Denmark | Acceptable 2024-09-27
|
2024-09-27 |