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Completed

NCT Number: NCT01474356

Hyperthermia Combined Brachytherapy in CCU

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Maria Skłodowska-Curie Memorial Cancer Center and Institute

Warsaw, 02-781, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermia

Other

45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2011
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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