Alternating chemotherapy plus cetuximab to allow resection of metastases from a colorectal cancer that is wild-type KRAS and BRAF - a randomised phase II trial - Nordic 7.6

Phase 1

• Conditions: MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Metastatic colorectal cancer with wild-type KRAS and BRAF; MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004188-65-SE
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Histology and stagesHistologically proven adenocarcinoma in the colon or rectum
- At least 1 measurable metastatic disease manifestation according to the RECIST criteria (version 1.1)
- Potentially completely resectable or potentially curable metastatic colorectal cancer as determined by the local MDT conference and that requires tumour shrinkage before resection is possible. The following definitions are indicative:
-- 4 or more liver metastases (CRLeM) without extra-hepatic disease
-- 2 or more lung metastases (CRLuM) without hepatic or extra-hepatic disease
-- 1 or more CRLeM determined as potentially resectable (such as because of location) by the local MDT.
-- 1 or more CRLuM determined by the local MDT as potentially resectable (such as because of location).
-- Non-resectable primary disease with resectable CRLeM or CRLuM.
KRAS and BRAF status
- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF
General conditions
- age > 18 years
- WHO performance status = 1;
- expected survival > 3 months
- sufficient bone-marrow function (Hb = 6.2 µmol/l/Hb > 10 g/dl ANC = 1.5 x 109/l, thrombocytes = 100 x 109/l)
- sufficient kidney and liver function: total bilirubin = 1.5 x upper normal limit, serum creatinine = 1.25 x upper normal limit, ALAT = 3 x upper normal limit and = 5 x upper normal limit with liver metastases
- the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous treatment
- previous chemotherapy for advanced/metastatic disease
- adjuvant chemotherapy unless completed more than 6 months before registration
- previous treatment with oxaliplatin or irinotecan
- previous treatment with cetuximab or other treatment for EGFR
- History of Inflammatory Bowel disease
- Severe or uncontrolled cardiovascular disease, congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
- Any condition that, according to the treating physician's judgement, could prevent the planned medical/surgical treatment from being carried out responsibly (such as uncontrolled active infection, known hypersensitivity or contra-indication for the planned treatment.
- Pregnant or breast-feeding women
- Patients of fertile age who do not want to use reliable contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate (RR) estimate by the investigator;<br> Secondary Objective: To evaluate and determine <br> Progression-free survival (PFS).<br> Survival.<br> Treatment safety and toxicity.<br> Frequency of secondary surgical resection (R0 + R1 + R2 resections).<br> Frequency of secondary micro-radical surgical resection (R0 resection).<br> Frequency of other radical local treatment, such as RFA or MWA.<br> ;<br> Primary end point(s): To determine and evaluate response rate (RR)<br> ;Timepoint(s) of evaluation of this end point: 5 years

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Frequency of surgical resection<br> Progression-free survival (PFS)<br> Survival<br> Treatment safety and toxicity<br> ;Timepoint(s) of evaluation of this end point: 5 years