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Hyperthermia Combined Brachytherapy in CCU

NCT01474356 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2011-11-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

hyperthermia

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

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Agnieszka Żółciak-Siwińska, PhD · M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474356 on ClinicalTrials.gov