Hyperthermia Combined Brachytherapy in CCU

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474356
• Other study ID #: HTCCU01
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: November 15, 2011
• Start date: November 2006
• Est. completion date: March 2009

Study information

• Verified date: November 2011
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Director of Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw Prof Reinfuss.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Fever
• Uterine Cervical Neoplasms

Intervention

Other:
• hyperthermia
45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LC	When local relapse was suspected, biopsy was obtained.	Follow up was scheduled every 3 months. Preliminary results after 3 years.	Yes
Secondary	Late side effects	EORTC\ERTOG scale for rectum and bladder and SOMA scale for vagina	Follow up was scheduled every 3 months. Preliminary results after 3 years.	Yes
Secondary	Early complications of BT procedure	Reporting the episodes of perforation and bleeding.	24 hours after BT procedure	Yes
Secondary	DFS	CT, RTG, MRJ, SCC are performed to detect metastases.	Follow up was scheduled every 3 months. Preliminary results after 3 years.	Yes