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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2022-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Colorectal Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bevacizumab plus s-1

Group Type EXPERIMENTAL

S-1

Intervention Type 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 plus capecitabin

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type 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

Intervention Type DRUG

Capecitabine 2000mg/m2/d is administered orally on days 1 to 14 of a 21-day cycle.

Interventions

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S-1

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).

Intervention Type DRUG

Bevacizumab

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.

Intervention Type DRUG

Capecitabine

Capecitabine 2000mg/m2/d is administered orally on days 1 to 14 of a 21-day cycle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained); 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.

Ongoing or planned first line treatment with 6 cycles of Xeloda, Eloxatin, and Avastin.