JPRN-UMIN000013000
Recruiting
Phase 2
Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer - pedioperative chemotherapy study of XELOX +bevacizumab for locally advanced rectal cancer.(RUDDER Trial)
Sano Hospital Masahito Kotaka, MD0 sites50 target enrollmentJanuary 28, 2014
ConditionsRectal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rectal cancer
- Sponsor
- Sano Hospital Masahito Kotaka, MD
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Need to drain malignant coelomic fluid; 2\.Multiple primary cancer within 5years 3\. Bleeding tendency, coagulation factor or abnormal clotting disorder (INR 1\.5\) 4\. Intestinal paralysis, intestinal obstruction, peptic ulcer uncontrollable 5\.Serious complications (diabetes, infections, diarrhea) 6\. Symptomatic or asymptomatic but treated heart disease. History of those within one year prior to enrollment 7\. History of the serious hypersensitivity for fluorouracil, platinum compound. History of adverse events related to DPD loss 8\. Peripheral sensory neuropathy (CTCAE v4\.0 Grade 1\); 9\.Pulmonary fibrosis or interstitial pneumonia 10\. Current or previous (within the last 1 year) history of cerebrovascular disease 11\.Administered antithrombotic agents for thrombosis within 10 days prior to enrollment 12\. Serious hypertension 13\. History of gastrointestinal perforation 14\.Pregnant women,possibly pregnant women, wishing to become pregnant, and nursing mothers; 15\.No intention to practice birth control; 16\.Previously treated with oxaliplatin;or capecitabine 17\.Any other medical conditions disable to comply with the protocol
Outcomes
Primary Outcomes
Not specified
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