Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer

Phase 2

• Conditions: ow rectal cancer

• Registration Number: JPRN-UMIN000013598
• Lead Sponsor: Toho University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-01
• Study Completion: 2018-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of pathological complete response

Secondary Outcome Measures

Name	Time	Method
Safety