Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
- Conditions
- Rectal cancer of Stage II or III with T4 or lateral lymph node metastasis at the pre-operative diagnosis
- Registration Number
- JPRN-UMIN000002845
- Lead Sponsor
- ational cancer center hosital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
1. Suspected metastasis of external iliac lymph nodes, para-aortic lymph nodes, or inguinal lymph nodes by pelvic MRI. 2. Prior or synchronous invasive malignancy (expect carcinoma in situ or superficial carcinoma which is able to eradicate by local therapy) unless disease free for a minimum of 5 years 3. Evidence of active bacterial or fungal infection (existing fever above 38 degrees centigrade due to infection) 4. Previous history of severe drug-induced allergy 5. Need to treatment with flucytosine, atazanavir sulfate, or warfalin 6. Need systemic administration of corticosteroids 7. Evidence of positive hepatitis B virus surface antigen 8. Evidence of severe watery diarrhea 9. Evidence of uncontrolled diabetic mellitus 10. Evidence of uncontrolled hypertension 11. Need to intervention for heart disease according to the findings of electrocardiogram within the last 28 days 12. Myocardial infarction or unstable angina pectoris within the last 12 months 13. Major surgery within 4 weeks of study enrollment (other than diverting colostomy) 14. Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, advanced emphysema, heart disease which is difficult to manage, renal failure, hepatic failure) 15. Pregnant or lactating and woman with childbearing potential who lacked effective contraception 16. Evidence of psychiatric disability interfering with enrollment to clinical trial 17.Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the MTD and RD of oxaliplatin
- Secondary Outcome Measures
Name Time Method Adverse events, radiologic and pathologic tumor response, surgical morbidity