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Hyperthermia Combined Brachytherapy in CCU

NCT ID: NCT01474356

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Keywords

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brachytherapy interstitial hyperthermia cervical cancer side effects Locally advanced cervical cancer patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

hyperthermia

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

hyperthermia

Intervention Type OTHER

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

Interventions

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hyperthermia

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnieszka Żółciak-Siwińska, PhD

Role: STUDY_CHAIR

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

Locations

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Maria Skłodowska-Curie Memorial Cancer Center and Institute

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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HTCCU01

Identifier Type: -

Identifier Source: org_study_id