A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Phase 2
- Conditions
- rectal cancer
- Registration Number
- JPRN-UMIN000023621
- Lead Sponsor
- Department of Surgery Kindai University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
# Distant metastases # Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year. # Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year. # Cancerous fluid on diagnostic imaging. # Prior chemotherapy or pelvic irradiation for malignancy. # Other cancer diagnosis within the past 5 years (including colorectal cancer). # Interstitial pneumonia or fibroid lung. # Uncontrolled diabetes mellitus. # Uncontrolled hypertension # Ileus (cases with diverting stoma are eligible). # Uncontrolled diarrhea. # Pregnant, nursing or no intention to contraception. # Those considered inappropriate for participation in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate
- Secondary Outcome Measures
Name Time Method Response rate, overall and disease-free survival, quality of life, adverse events, postoperative complications, pathological complete response rate, and diagnostic accuracy of MRI