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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy
Maria Skłodowska-Curie Memorial Cancer Center and Institute
Warsaw, Poland
LC
When local relapse was suspected, biopsy was obtained.
Time frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
Late side effects
EORTC\\ERTOG scale for rectum and bladder and SOMA scale for vagina
Time frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
Early complications of BT procedure
Reporting the episodes of perforation and bleeding.
Time frame: 24 hours after BT procedure
DFS
CT, RTG, MRJ, SCC are performed to detect metastases.
Time frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
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