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

NCT01918852 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2018-03-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Capecitabine

DRUG

Teysuno

DRUG

Bevacizumab

Sponsors & Collaborators

  • Nordic Pharma SAS

    collaborator INDUSTRY

  • Dutch Colorectal Cancer Group

    lead OTHER

Principal Investigators

  • Cornelis JA Punt, Prof MD PhD · Amsterdam Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2018-03-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918852 on ClinicalTrials.gov