NIPH Clinical Trials Search

UMIN ID: UMIN000001639

Registered date:15/01/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedlocally advanced resectable rectal cancer
Date of first enrollment2009/02/01
Target sample size18
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeMaximum tolerated dose Recommended dose
Secondary OutcomeSafety R0 resection rate Down-staging rate pathological Complete Response rate

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1.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


public contact
Name SAMRAI affairs office
Address Toa-Bldg.4F, 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan Japan
Telephone 03-5401-5020
Affiliation The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency
scientific contact
Name Masahiko Watanabe
Address 1-15-1 Kitasato Minami-ku Sagamihara-City Kanagawa Japan
Telephone 042-778-8111
Affiliation Kitasato University School of Medicine Department of Surgery