Status:
COMPLETED
S-1 Versus Capecitabine in the First Line Treatment of MCC Patients.
Lead Sponsor:
Dutch Colorectal Cancer Group
Collaborating Sponsors:
Nordic Pharma SAS
Conditions:
Colorectal Cancer
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Pat...
Detailed Description
Capecitabine, an oral fluoropyrimidine, has shown a comparable efficacy but a better tolerability compared to bolus 5-FU/LV. However, capecitabine has a higher incidence of hand-foot syndrome (HFS). H...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01918852
Start Date
December 1 2013
End Date
March 1 2018
Last Update
March 14 2018
Active Locations (24)
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1
Medisch Centrum Alkmaar
Alkmaar, Netherlands
2
Meander Medisch Centrum
Amersfoort, Netherlands
3
Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
4
Academic Medical Centre
Amsterdam, Netherlands