A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).
- Conditions
- ntreated metastatic colorectal cancer
- Registration Number
- JPRN-jRCT1080220674
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 500
Histologically confirmed colorectal adenocarcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
- Age:20-79 years
- ECOG Performance status:0-1
- Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- No prior chemotherapy or radiotherapy(Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment)
- Adequate oral intake
- Adequate function of major organs
- Life expectancy of at least 3 months
- Voluntary written informed consent
- Serious drug hypersensitivity or a history of drug allergy
- Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
- Active infections (e.g., patients with pyrexia of 38 degrees C or higher)
- Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension)
- Remarkable electrocardiographic abnormality, or cardiac disease (cardiac failure, cardiac infarction, and angina pectoris)
- Gastrointestinal ulcer or bleeding
- Peripheral sensory neuropathy
- Serious diarrhea
- Ascites or pleural effusion requiring treatment
- Brain metastasis
- History of gastrointestinal perforation within 6 months
- History of thrombo-embolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
- Major surgical procedure within 4 weeks
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Concurrent treatment with anti-coagulation drug
- Active double cancer
- Prior treatment with oxaliplatin as adjuvant chemotherapy
- Continuous treatment with steroids
- Judged ineligible for participation in the study by the investigator
- Case who has primary lesion with severe stenosis that endoscope doesn't pass(e.g., primary resection or colostomy)
- Case who has peritoneum metastasis that can be confirmed by image
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival(PFS)
- Secondary Outcome Measures
Name Time Method Overall survival(OS)<br>Response rate(RR)<br>Disease control rate(DCR)<br>Time to progression(TTP)<br>Time to treatment failure(TTF)<br>Resection rate(R0-R)<br>Safety