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Hyperthermia Combined Brachytherapy in CCU

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ClinicalTrials.gov Identifier: NCT01474356
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : November 18, 2011
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: hyperthermia Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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U.S. FDA Resources

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



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


Secondary Outcome Measures :
  1. 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

  2. Early complications of BT procedure [ Time Frame: 24 hours after BT procedure ]
    Reporting the episodes of perforation and bleeding.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474356


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

Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT01474356     History of Changes
Other Study ID Numbers: HTCCU01
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
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