Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer
- Conditions
- High-risk Stage II or stage III colon and rectum cancer(above the peritoneal reflection)
- Registration Number
- JPRN-UMIN000012535
- Lead Sponsor
- Chubu Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Not provided
(1)Appendix cancer or anal cancer (2)Distal extent of tumor must be in the Rb (3)Multiple malignacies to be treated (4)Ileus, bowel obstruction or uncontrolled peptic ulcer. (5)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) (6)Massive pleural effusion or ascites that required drainage. (7) Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (8) A history of allergy to 5-FU, platina, or Known dihydropyrimidine dehydrogenase (DPD) deficiency. (9)Severe neuropathy (10)With interstitial lung disease or pulmonary fibrosis (11)Continuous systemic steroid therapy (oral or intravenous administration). (12)A history and/or current evidence of significant neurological and/or mental illness. (13)Pregnant (14)Without intention to contraception (15)Prior chemotherapy including Oxaliplatin or Capecitabin (16)Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method