Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer

Institut de Cancérologie de Lorraine48 enrolled

Overview

This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

* The causes of treatment failure and death in cervical cancer are still often linked to a local cancer progression * The importance of local control for healing, than the cervix situation in the center of pelvis between bladder and rectum which are sensitive organs to irradiation justify the use of utero-vaginal brachytherapy * This open label, multicenter, phase II study evaluates the benefit of increasing in dose to the target volume at high risk and the intermediate target volume in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer. * Local control and tolerance are evaluated

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Adenocarcinoma Stage IB Cervical Cancer Stage II Cervical Cancer Stage III Cervical Cancer

Interventions

External Beam Radiation TherapyRADIATION

45 Gy pelvis / 25 fr

PDR BrachytherapyRADIATION

1 puls/hour ; 12 Gy / day

CisplatinDRUG

increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * primitive cervical cancer * adenocarcinoma histologically advanced * IB2, II and III stage * curative treatment * indication of utero-vaginal brachytherapy with external radiotherapy * non-metastatic tumor and life expectancy \> 6 months * patient informed and follow possible * performance status ≤ 2 * unplanned surgery * age ≥ 18 years old * ability to provide written informed consent before the start of any study specific procedures Exclusion Criteria: * primitive endometrial cancer * other diseases * carcinoma in situ and stages ≤ B * distant metastases * history of pelvic irradiation or a first pelvic cancer * contraindication to MRI * history of subtotal or total hysterectomy * pregnant or breast feeding females * inability to support low dose rate continuous brachytherapy or pulsed flow * person in emergencies * person unable to give personally consent * patient participating in another clinical research except in case of local recurrence or observational research

Locations (9)

CHU de Besançon

Besançon, France

Institut Bergonié

Bordeaux, France

Centre Georges-François Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Outcomes

Primary Outcomes

Increase the local control rate

Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms

Time frame: 24 months

Secondary Outcomes

Maintain the cumulative rate grade III and IV complications below 6.5%

Time frame: 24 months

Relationship between the doses delivered to the target volume and local control

Time frame: 24 months

Relationship between the doses delivered to the critical organs and rate of grade III and IV complications

Time frame: 24 months

Data from ClinicalTrials.gov

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