Endometrial adenocarcinoma. Malignant neoplasm of endometrium
Conditions
Interventions
Intervention 1: High dose rate intravaginal brachytherapy with cylinder with total dose of 25 Gray in 5 continuous days during one week after surgery. Intervention 2: Control group: High dose rate int
Treatment - Other
High dose rate intravaginal brachytherapy with cylinder with total dose of 25 Gray in 5 continuous days during one week after surgery
Control group: High dose rate intravaginal brachytherapy with cylinder with total dose of 21 Gray in 3 continuous weeks during one week after surgery
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarnaz Amouzgar hashemi
Tehran University of Medical Sciences
Outcome results
None listed