Cervical Cancer
Conditions
Keywords
brachytherapy, interstitial hyperthermia, cervical cancer, side effects, Locally advanced cervical cancer patients
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.
Interventions
OTHERhyperthermia
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LC | Follow up was scheduled every 3 months. Preliminary results after 3 years. | When local relapse was suspected, biopsy was obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late side effects | Follow up was scheduled every 3 months. Preliminary results after 3 years. | EORTC\\ERTOG scale for rectum and bladder and SOMA scale for vagina |
| Early complications of BT procedure | 24 hours after BT procedure | Reporting the episodes of perforation and bleeding. |
| DFS | Follow up was scheduled every 3 months. Preliminary results after 3 years. | CT, RTG, MRJ, SCC are performed to detect metastases. |
Countries
Poland
Outcome results
None listed