EUCTR2011-004188-65-SE
Active, not recruiting
Phase 1
Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 7.6 - Nordic 8
ConditionsMetastatic colorectal cancer with wild-type KRAS and BRAFMedDRA 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)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)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)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic colorectal cancer with wild-type KRAS and BRAF
- Sponsor
- Odense University Hospital
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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