Hyperthermia Combined Brachytherapy in CCU

Study Overview
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Brief Summary
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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.

Official Title
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HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: hyperthermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: BT (brachytherapy)<br>Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed. | Other: hyperthermia<br>* 45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy<br>|
| Experimental: BTHT (brachytherapy and hyperthermia)<br>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. | Other: hyperthermia<br>* 45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LC | When local relapse was suspected, biopsy was obtained. | Follow up was scheduled every 3 months. Preliminary results after 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late side effects | EORTC\ERTOG scale for rectum and bladder and SOMA scale for vagina | Follow up was scheduled every 3 months. Preliminary results after 3 years. | 
| Early complications of BT procedure | Reporting the episodes of perforation and bleeding. | 24 hours after BT procedure | 
| DFS | CT, RTG, MRJ, SCC are performed to detect metastases. | Follow up was scheduled every 3 months. Preliminary results after 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brachytherapy, interstitial hyperthermia, cervical cancer, side effects, Locally advanced cervical cancer patients