Investigating the clinical response rate of patients with lower rectal cancer after combined treatment with intensity-modulated chemoradiotherapy and pre-surgical chemotherapy
Phase 2
Recruiting
- Conditions
- rectal cancer.Malignant neoplasm of rectum
- Registration Number
- IRCT20150929024266N6
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Non-metastatic rectal cancer (>T2N0) that is less than 5 cm from the anal wedge
Exclusion Criteria
Inability to do MRI (whether mechanical or claustrophobia)
Lack of proper MRI for disease staging
Multiple comorbidities
Inadequate blood, kidney, or liver indices for the possibility of receiving chemotherapy
History of previous malignancies in the pelvis or other areas of the intestine, history of previous surgeries or radiotherapy in the pelvic area
MSI-H patients who are candidates for immunotherapy
History of IBD or FAP and other colon polyposis syndromes
Active malignancies in other areas of the body.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of clinical response in MRI and colonoscopy. Timepoint: 12 to 16 weeks after completion of treatment. Method of measurement: Reduction in size or complete disappearance of mass in MRI and colonoscopy.
- Secondary Outcome Measures
Name Time Method