Phase I/II study of TS-1 / Oxaliplatin / Cetuximab / Radiation for KRAS wild type locally advanced and recurrent rectal cancer.
Phase 1
Recruiting
- Conditions
- advanced and recurrent rectal Cancer
- Registration Number
- JPRN-UMIN000006304
- Lead Sponsor
- Graduate School of Medicine, Osaka Univesity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Not provided
Exclusion Criteria
1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2) No radiation therapy 3) Allergic to a drug 4) Patients under treatment with flucytosine. 5) Sensory neuropathy 6) Metastasis to CNS. 7) Intestinal paralysis or ileus 8) Massive pleural or abdominal effusion. 9) Active infection and inflammation. 10) Watery stools or diarrhea. 11) Severe complications 12) Pregnant or lactating 13) Other patients who are unfit for the study as determined by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:To determine maximum tolerated dose and recommended dose. Phese II:pCR rate.
- Secondary Outcome Measures
Name Time Method