The Efficacy and Feasibility Study of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer (Est-Neo)
- Conditions
- Rectal Cancer
- Registration Number
- JPRN-UMIN000005654
- Lead Sponsor
- Gastro-intestinal Sugery Division, Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Not provided
# 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 infection. # Current symptoms of neuropathy, defined as >= grade 2 neurosensory or neuromotor toxicity. # Ileus (cases with diverting stoma are eligible). # Uncontrolled diarrhea. # Pregnant, nursing or no intention to contraception. # Contraindication for the administration of bevacitumab (In the cases of KRAS mutant-type) # 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 DFS, RFS, OS, local recurrence rate, Incidence of (severe) adverse event, Incidence of postoperative morbidity, Incidence of sexual dysfunction (male only), Incidence of urinary and anal dysfunction, Clinical response, Relative dose intensity, Chemotherapy completion rate