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

Sponsor
Dutch Colorectal Cancer Group
Study ID
NCT01918852
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
  • Teysuno — DRUG
  • Bevacizumab — DRUG

Study Details

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

Key Dates

First listed
Aug 8, 2013
Start date
Dec 31, 2013
Status verified
Mar 2018
Primary completion
Dec 31, 2015
Completion
Mar 31, 2018

Study Design

Enrollment
161 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Capecitabine
    Capecitabine 1250 mg/m2 for patients \< 70 years of age, and 1000 mg/m2 for patients ≥ 70 years of age, orally b.i.d. day 1-14 with or without bevacizumab 7.5 mg/kg i.v. day 1.
  • Experimental: S1
    S-1 30 mg/m2 orally b.i.d. irrespective of age, day 1-14 with or without bevacizumab 7.5 mg/kg i.v. day 1.

Primary Outcome Measure

Incidence of HFS in first line treatment [ Time Frame: HFS will be assessed every 3 weeks up to 6 months average. ]

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