Hyperthermia Combined Brachytherapy in CCU

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01474356
First received: October 20, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Other: hyperthermia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • LC [ Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years. ] [ Designated as safety issue: Yes ]
    When local relapse was suspected, biopsy was obtained.


Secondary Outcome Measures:
  • Late side effects [ Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years. ] [ Designated as safety issue: Yes ]
    EORTC\ERTOG scale for rectum and bladder and SOMA scale for vagina

  • Early complications of BT procedure [ Time Frame: 24 hours after BT procedure ] [ Designated as safety issue: Yes ]
    Reporting the episodes of perforation and bleeding.

  • DFS [ Time Frame: Follow up was scheduled every 3 months. Preliminary results after 3 years. ] [ Designated as safety issue: Yes ]
    CT, RTG, MRJ, SCC are performed to detect metastases.


Enrollment: 224
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01474356

Locations
Poland
Maria Skłodowska-Curie Memorial Cancer Center and Institute
Warsaw, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
Study Chair: Agnieszka Żółciak-Siwińska, PhD M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland
  More Information

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01474356     History of Changes
Other Study ID Numbers: HTCCU01
Study First Received: October 20, 2011
Last Updated: November 15, 2011
Health Authority: Poland: Director of Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw Prof Reinfuss.

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
brachytherapy
interstitial hyperthermia
cervical cancer
side effects
Locally advanced cervical cancer patients

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Fever
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014