Hyperthermia Combined Brachytherapy in CCU

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Completed; Phase 3

Conditions: Cervical Cancer

Treatments: Other: hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT01474356

HTCCU01

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

BT (brachytherapy)

No Intervention group

Description:

Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.

Treatment:

Other: hyperthermia

BTHT (brachytherapy and hyperthermia)

Experimental group

Description:

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.

Treatment:

Other: hyperthermia