S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer

UMIN ID: UMIN000001639

Registered date:15/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: locally advanced resectable rectal cancer
• Date of first enrollment: 2009/02/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): TS-1:day1-5,8-12, 22-26,29-33 CPT-11:day1,8,22,29 Radiotherapy: 5 times a week for 5 weeks

Outcome(s)

• Primary Outcome: Maximum tolerated dose Recommended dose
• Secondary Outcome: Safety R0 resection rate Down-staging rate pathological Complete Response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Previous history of severe drug-induced allergy 2.Multiple malignancies to be treated or synchronous colorectal cancer 3.Need to treatment with flucytosine or atazanavir sulfate 4. Patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6 5. Active infections 6. Serious complications 7.Previous history of Interstitial Pneumonitis 8.Pleural effusion or ascites requiring treatment. 9. Active digestive tract bleeding 10. Severe watery diarrhea 11. Pregnant or nursing 12.Systemic administartion of corticosteroids 13. Patients of hepatitis B virus suface antigen positivity 14. Patients judged inappropriate for this study by the physicians

Related Information

• Primary Sponsor: The Tokyo Cooperative Oncology Group
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO.,LTD