The effectiveness of the total neoadjuvant therapy in in rectal adenocarcinoma patients
Phase 1
- Conditions
- Rectal adenocarcinoma.Malignant neoplasm of rectum
- Registration Number
- IRCT20220723055527N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients with rectal adenocarcinoma based on pathological diagnosis
The zero to two level of Eastern Cooperative Oncology Group (ECOG)
Healthy functioning bone marrow
Healthy functioning liver
Healthy functioning kidneys
Exclusion Criteria
Having simultaneous adenocarcinoma in other areas of the colon
Having metastasis
History of previous malignancy
History of chemotherapy
History of pelvic radiotherapy
Having inflammatory intestinal disease
Having bilateral hip prosthesis
Having allergic to 5-fluorouracil and its other derivatives
Having allergic to oxaliplatin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pathological complete response. Timepoint: One week after surgery. Method of measurement: Based on surgical pathology report.;Local recurrence. Timepoint: One year after intervention. Method of measurement: Pelvic computed tomography (CT) scan and colonoscopy.;Distant metastasis. Timepoint: One year after intervention. Method of measurement: Abdominal and pelvic CT scan.
- Secondary Outcome Measures
Name Time Method Complications of treatment. Timepoint: One, two and three weeks after treatment. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE).