NCT01474356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

October 20, 2011

Last Update Submit

November 15, 2011

Conditions

Cervical Cancer

Keywords

brachytherapyinterstitial hyperthermiacervical cancerside effectsLocally advanced cervical cancer patients

Outcome Measures

Primary Outcomes (1)

  • LC

    When local relapse was suspected, biopsy was obtained.

    Follow up was scheduled every 3 months. Preliminary results after 3 years.

Secondary Outcomes (3)

  • Late side effects

    Follow up was scheduled every 3 months. Preliminary results after 3 years.

  • Early complications of BT procedure

    24 hours after BT procedure

  • DFS

    Follow up was scheduled every 3 months. Preliminary results after 3 years.

Study Arms (2)

BT (brachytherapy)

NO INTERVENTION

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

BTHT (brachytherapy and hyperthermia)

EXPERIMENTAL

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

Interventions

hyperthermiaOTHER

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

BT (brachytherapy)BTHT (brachytherapy and hyperthermia)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with locally advanced cervical cancer FIGO stage II - III
  • signed informed consent for participation in the study

You may not qualify if:

  • patients with FIGO stage I and IV
  • patients with poor performance status with contraindications for radical treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Skłodowska-Curie Memorial Cancer Center and Institute

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Agnieszka Żółciak-Siwińska, PhD

    M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

November 18, 2011

Study Start

November 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

PL(1)