Clinical trial · Interventional
Hyperthermia Combined Brachytherapy in CCU
HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperthermia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- BT (brachytherapy)
- description
- Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.
- interventionNames
- Other: hyperthermia
- type
- EXPERIMENTAL
- label
- BTHT (brachytherapy and hyperthermia)
- description
- Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy with interstitial hyperthermia was performed.
- interventionNames
- Other: hyperthermia
Primary outcomes (1)
- measure
- LC
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available