Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutatio
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000014892
- Lead Sponsor
- iigata Colorectal Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
1)Presence of severe drug allergy 2)Pregnant patients 3)Active infection(>=38.0C) 4) Presence of severe complication(interstitial pneumonia or lung fibrosis, renal failure, liver failure, Poorly controlled diabetes mellitus poorly controlled hypertension 5) Remarkable ECG change or clinical heart disease (heart failure, AMI, angina) 6)Active gastric bleeding or gastric ulcer 7)Peripheral neuropathy 8)Severe diarrhea 9)Pleural effusion or ascites needed to treat 10)Gastrointestinal perforation in 6 months (without obstractive colorectal cancer) 11)Thromboembolism or cerebral infarction(without asymptomatic lacunar infarction ), pulmonary infraction, intestinal pneumonia 12)Operation within 28days (an exception of implanting central venous reservoir) 13)Congenital hemorrhagic diathesis or coagulopathy 14)Other active malignancies of DFS is within 5years (except for the case skin basal carcinoma and cervical cancer be cured or Stomach cancer, esophageal cancer, colorectal pM cancer that was confirmed cured by an endoscopic treatment) 15)Needed to dosage systemic steroid 16)Evaluated to be ineligible by a physician for other reasons 17)Hemoptysis( more than 2.5ml) 18)Contraindication of L-OHP ,CPT-11, BV , TS-1 19)Primary tumor with severe stenosis that an endoscope does not pass(Except for the case that constructed excision of the primary tumor or the artificial anus) 20)Peritoneum metastasis confirmed with an image.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Second progression free survival
- Secondary Outcome Measures
Name Time Method .Overall survival .Transfer ratio of 2nd line chemotherapy .Term of 1st line chemotherapy to 2nd line chemotherapy Each of the 1st line and 2nd line chemotherapy .Progression Free Survival: PFS .Time to treatment failure: TTF .Relative dose intensity: RDI .Response Rate .Frequency and Grade of Adverse Event .Term of hospitalization and frequency of visiting the hospital .Biomarker analysis