Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.
Phase 1
Recruiting
- Conditions
- ocally advanced rectal cancer with preoperative diagnosis of T3-4 and N0-3.
- Registration Number
- JPRN-UMIN000006208
- Lead Sponsor
- The University of Tokyo Hospital. Department of surgical oncology.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
Not provided
Exclusion Criteria
1.Allergic to a drug 2.Contraindications to UFT, Leucovorin and Irinotecan 3.Active infection 4.UGT1A: *6/*6, *28/*28 and *6/*28 5.Severe complications such as ileus, interstitial pneumonia, DM, heart failure, lung failure and liver failure 6.Pregnant or planning to get pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD and RD are determined by step 1. Histopathological effects are primary endpoints of step 2.
- Secondary Outcome Measures
Name Time Method Ratio of downstaging, rate of local recurrence, disease free survival and occurrence of adverse events are secondary outcomes of step 2.