Colorectal Adenocarcinoma
Conditions
Keywords
bevacizumab, s-1, capecitabin, maintenance
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
Interventions
DRUGS-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).
DRUGBevacizumab
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.
DRUGCapecitabine
Capecitabine 2000mg/m2/d is administered orally on days 1 to 14 of a 21-day cycle.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Criteria Before the start of induction therapy: 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.
Exclusion criteria
Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment Any prior adjuvant treatment after resection of distant metastases Previous systemic treatment for advanced disease At randomisation: Inclusion criteria: WHO performance status 0-1 (Karnofsky PS \> 70%); Disease evaluation with proven SD, PR or CR according to RECIST after 6 cycles of MTD chemotherapy performed in week 3-4 of the 6th cycle induction therapy, and randomisation performed in week 3-5 of the 6th cycle (see time table); Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb \> 6.0 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, \> 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases); Life expectancy \> 12 weeks; Age \>= 18 yrs; Negative pregnancy test in women with childbearing potential; Expected adequacy of follow-up; Institutional Review Board approval; Written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From enrollment to progression of disease. Estimated about 6 months. | The length of time from enrollment until the time of progression of disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From enrollment to death of patients. Estimated about 1 year. | The length of time from enrollment until the time of death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | From enrollment to 3 months after treatment | According to NCI CTCAE 4.03 criteria |
Countries
China
Outcome results
None listed