Hyperthermia Combined Brachytherapy in CCU
This study has been completed.
Sponsor:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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
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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
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 May 19, 2013