S-1 Versus Capecitabine in the First Line Treatment of MCC Patients.

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a two-arm randomised phase III trial. Patients will be randomised to receive capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles for response. Upon disease progression patients will be treated according to the local investigators

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dutch Colorectal Cancer Group
• Collaborator: Nordic Pharma SAS
• Treatments: Bevacizumab; Capecitabine

Criteria

Inclusion Criteria:

• Histological proof of colorectal cancer.

• Distant metastases (patients with only local recurrence are not eligible).

• Unidimensionally measurable disease (≥1 cm on spiral CT scan or ≥2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation.

• In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.

• Age ≥ 18 years

• Planned treatment with fluoropyrimidine monotherapy with or without bevacizumab.

• WHO performance status 0-2 (Karnofsky PS ≥70%)

• Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥1.5 x 109/L, platelets ≥ 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, ≥30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases).

• Life expectancy > 12 weeks.

• Negative pregnancy test in women with childbearing potential.

• Expected adequacy of follow-up.

• Institutional Review Board approval.

• Written informed consent.

Exclusion Criteria:

• Prior adjuvant treatment for stage II/III colorectal cancer completed within 6 months prior to randomisation.

• Any prior adjuvant treatment after resection of distant metastases.

• Any previous systemic treatment for metastatic disease.

• History or clinical signs/symptoms of CNS metastases.

• History of a second malignancy <5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.

• Previous intolerance of capecitabine.

• Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.

• Planned radical resection of metastases after downsizing by systemic treatment.

• Significant cardiovascular disease < 1 yr before randomisation (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, pulmonary embolism).

• Any significant cardiovascular events during previous fluoropyrimidine therapy.