Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Phase 1
Recruiting
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000002602
- Lead Sponsor
- Yokohama City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Patients were excluded if they had prior RT to the pelvic region or previous cytotoxic chemotherapy or if they had other synchronous cancers. Patients suffering from the following conditions were also ineligible: inflammatory bowel disease, malabsorption syndrome, ischemic heart disease, peripheral neuropathy, and psychiatric disorders or psychologic disabilities thought to adversely affect treatment compliance. In addition, pregnant or lactating patients and women with childbearing potential who lacked effective contraception were excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate
- Secondary Outcome Measures
Name Time Method Dose-limiting toxicities (DLTs) Complication rate R0 resection rate downstaging rate