Hyperthermia Combined Brachytherapy in CCU

Phase 3

Completed

• Conditions: Cervical Cancer
• Interventions: Other: hyperthermia

• Registration Number: NCT01474356
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2011-10-20
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-18
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTHT (brachytherapy and hyperthermia)	hyperthermia	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.
BT (brachytherapy)	hyperthermia	Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.

Primary Outcome Measures

Name	Time	Method
LC	Follow up was scheduled every 3 months. Preliminary results after 3 years.	When local relapse was suspected, biopsy was obtained.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maria Skłodowska-Curie Memorial Cancer Center and Institute; 🇵🇱 Warsaw, Poland