Evaluation of treatment outcome of induction chemotherapy and then Neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer
Phase 2
- Conditions
- Malignant neoplasm of rectumlocally advanced rectal cancer.
- Registration Number
- IRCT20200420047139N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
rectal cancer lower than 15 cm anal verge
T3 or T4 or N+
2 = performance status
GFR = 50
liver function test upper limit normal
bilirubin lower than 3rd upper limit normal
more than 18 years , less thean 65 years
Exclusion Criteria
pathology except adenocarcinoma
T1,2 ,N0
metastatic disease
history of malignancy
history of chemotherapy or radiation therapy
pregnancy and breast feeding
recurrent rectal cancer
medical disease
forrbidden chemotherapy or radiation therapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic complete response. Timepoint: after surgery. Method of measurement: pathologic evaluation.
- Secondary Outcome Measures
Name Time Method Grade 3 or more of acute toxicity. Timepoint: during chemotherapy and chemoradiation. Method of measurement: observation symptoms and lab test.;R0 Resection. Timepoint: after surgery. Method of measurement: pathology.;Sphincter pereservation. Timepoint: after surgery. Method of measurement: type of surgery.