Phase II trial of induction mFOLFOX6 plus Avastin followed by neoaduvant chemoradiotherapy with TS-1 for MRI-defined high-risk rectal cancer (IMPACT-RC)
- Conditions
- Resectable locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000011457
- Lead Sponsor
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 76
Not provided
1) Contraindication for either of S-1, Oxaliplatin, 5-FU, Leucovorin or Bevasizumab 2) Past history of severe hypersensitivity to the drugs 3) Past history of irradiation to the pelvis 4) Presence of infection with fever 5) Presence of severe morbidity such as heart failure, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, renal failure and liver failure. 6) Presence of sensory neuropathy 7) Presence or clinical manifestation of brain metastasis 8) Presence of diarrhea daily 9) Presence of ascites and/or pleural effusion which need aspiration 10) Presence of concomitant malignancy or past history of malignancy within five years 11) Female with pregnancy 12) Male who desire to keep fertility 13) Other inappropriate cases judged by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method