A comparison between adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
Phase 2
- Conditions
- Endometrial adenocarcinoma.Malignant neoplasm of endometrium
- Registration Number
- IRCT20161123031040N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 104
Inclusion Criteria
Patients who suffer from endometrial adenocarcinoma stage 1 or 2
Patient's age will be between 18 to 75 years
Patients who have underwent total abdominal hysterectomy and bilateral sapping-oophorectomy
Karnofski Performance Status should be more than 70
Exclusion Criteria
Patient receive other adjuvant therapies like chemotherapy.
Histological pathology of papillary serous carcinoma or clear cell carcinoma
Presence of commodities like severe hypertension or myocardial infarction
Patient refuses the treatment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rectal complication. Timepoint: Evaluation of rectal complications 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: History, physical examination and proctosigmoidoscopy if indicated.;Urinary complications. Timepoint: Evaluation of urinary complications 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: History, physical examination and urine analysis if indicated.;Vaginal complications. Timepoint: Evaluation of vaginal complications 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: History and physical examination.
- Secondary Outcome Measures
Name Time Method Response rate. Timepoint: Assessment of tumor size at the beginning and 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: Assessment of tumor size through vaginal exam.;Pelvic recurrence. Timepoint: Assessment of pelvic recurrence 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: History and physical exam.;Vaginal recurrence. Timepoint: Assessment of vaginal recurrence 4, 8 and 12 months after vaginal cuff brachytherapy. Method of measurement: History and physical exam.