HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 224
- Locations
- 2
- Primary Endpoint
- LC
Study Overview
Brief Summary
The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with locally advanced cervical cancer FIGO stage II - III
- •signed informed consent for participation in the study
Exclusion Criteria
- •patients with FIGO stage I and IV
- •patients with poor performance status with contraindications for radical treatments
Outcomes
Primary Outcomes
LC
Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
When local relapse was suspected, biopsy was obtained.
Secondary Outcomes
- Early complications of BT procedure(24 hours after BT procedure)
- Late side effects(Follow up was scheduled every 3 months. Preliminary results after 3 years.)
- DFS(Follow up was scheduled every 3 months. Preliminary results after 3 years.)