Hyperthermia Combined Brachytherapy in CCU

November 15, 2011 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-781
        • Maria Skłodowska-Curie Memorial Cancer Center and Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: BT (brachytherapy)
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
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy
EXPERIMENTAL: BTHT (brachytherapy and 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.
Other: hyperthermia
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LC
Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
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
Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
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
Time Frame: 24 hours after BT procedure
Reporting the episodes of perforation and bleeding.
24 hours after BT procedure
DFS
Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
CT, RTG, MRJ, SCC are performed to detect metastases.
Follow up was scheduled every 3 months. Preliminary results after 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

  • Study Chair: Agnieszka Żółciak-Siwińska, PhD, M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTCCU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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