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Hyperthermia Combined Brachytherapy in CCU

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
hyperthermia
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring brachytherapy, interstitial hyperthermia, cervical cancer, side effects, Locally advanced cervical cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maria Skłodowska-Curie Memorial Cancer Center and Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

BT (brachytherapy)

BTHT (brachytherapy and hyperthermia)

Arm Description

Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.

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.

Outcomes

Primary Outcome Measures

LC
When local relapse was suspected, biopsy was obtained.

Secondary Outcome Measures

Late side effects
EORTC\ERTOG scale for rectum and bladder and SOMA scale for vagina
Early complications of BT procedure
Reporting the episodes of perforation and bleeding.
DFS
CT, RTG, MRJ, SCC are performed to detect metastases.

Full Information

First Posted
October 20, 2011
Last Updated
November 15, 2011
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01474356
Brief Title
Hyperthermia Combined Brachytherapy in CCU
Official Title
HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
brachytherapy, interstitial hyperthermia, cervical cancer, side effects, Locally advanced cervical cancer patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BT (brachytherapy)
Arm Type
No Intervention
Arm Description
Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.
Arm Title
BTHT (brachytherapy and hyperthermia)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
hyperthermia
Intervention Description
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy
Primary Outcome Measure Information:
Title
LC
Description
When local relapse was suspected, biopsy was obtained.
Time Frame
Follow up was scheduled every 3 months. Preliminary results after 3 years.
Secondary Outcome Measure Information:
Title
Late side effects
Description
EORTC\ERTOG scale for rectum and bladder and SOMA scale for vagina
Time Frame
Follow up was scheduled every 3 months. Preliminary results after 3 years.
Title
Early complications of BT procedure
Description
Reporting the episodes of perforation and bleeding.
Time Frame
24 hours after BT procedure
Title
DFS
Description
CT, RTG, MRJ, SCC are performed to detect metastases.
Time Frame
Follow up was scheduled every 3 months. Preliminary results after 3 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Żółciak-Siwińska, PhD
Organizational Affiliation
M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Maria Skłodowska-Curie Memorial Cancer Center and Institute
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland

12. IPD Sharing Statement

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Hyperthermia Combined Brachytherapy in CCU

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