Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma

Sponsor
Fujian Cancer Hospital
Study ID
NCT03708536
Phase
PHASE3
Status
Withdrawn

Conditions

  • Colorectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • S-1 — DRUG
    S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2).
  • Bevacizumab — DRUG
    Bevacizumab (7.5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 3-week cycle.
  • Capecitabine — DRUG
    Capecitabine 2000mg/m2/d is administered orally on days 1 to 14 of a 21-day cycle.

Study Details

Bevacizumab plus capecitabin is a standard maintenance treatment following first-line chemotherapy in the patients with advanced colorectal adenocarcinoma. However, hand-foot syndrome induced by capecitabin will bother the patient to decrease the quality of life. S-1, an alternative of fluoropyrimidine, was proved non-inferior efficacy with lower hand-foot syndrome as first-line chemotherapy in advanced colorectal adenocarcinoma in the studies. The investigators are going to test the efficacy and safety of bevacizumab plus S-1 as maintenance treatment compared with bevacizumab plus capecitabin in colorectal adenocarcinoma

Key Dates

First listed
Oct 17, 2018
Start date
Nov 30, 2018
Status verified
Oct 2018
Primary completion
Nov 30, 2021
Completion
Nov 30, 2022

Study Design

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

Arms

  • Experimental: bevacizumab plus s-1
  • Active Comparator: bevacizumab plus capecitabin

Primary Outcome Measure

PFS [ Time Frame: From enrollment to progression of disease. Estimated about 6 months. ]

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