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

NCT03708536 | Withdrawn Phase 3 DMC

• 1 other identifier: FNF 012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Adenocarcinoma

Keywords

bevacizumab; s-1; capecitabin; maintenance

Outcome Measures

Primary Outcomes (1)

• PFS

  The length of time from enrollment until the time of progression of disease

  From enrollment to progression of disease. Estimated about 6 months.

Secondary Outcomes (1)

• Overall survival

  From enrollment to death of patients. Estimated about 1 year.

Other Outcomes (1)

• Toxicity

  From enrollment to 3 months after treatment

Study Arms (2)

bevacizumab plus s-1

EXPERIMENTAL

Drug: S-1

bevacizumab plus capecitabin

ACTIVE COMPARATOR

Drug: Bevacizumab; Drug: Capecitabine

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 plus s-1

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.

bevacizumab plus capecitabin

Capecitabine DRUG

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

bevacizumab plus capecitabin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• At randomisation:

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

S 1 (combination); Bevacizumab; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 17, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: March 8, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)