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

Phase 2

Completed

• Conditions: Stage III Cervical Cancer; Cervical Adenocarcinoma; Stage IB Cervical Cancer; Stage II Cervical Cancer
• Interventions: Radiation: External Beam Radiation Therapy; Radiation: PDR Brachytherapy; Drug: Cisplatin

• Registration Number: NCT02880007
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

* 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 Timeline

• Study Start: 2011-06-06
• Primary Completion: 2014-02-10
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Study Completion: 2019-07-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM A	PDR Brachytherapy	Dose Optimization in 3D Pulsed Dose Rate Brachytherapy
ARM A	External Beam Radiation Therapy	Dose Optimization in 3D Pulsed Dose Rate Brachytherapy
ARM A	Cisplatin	Dose Optimization in 3D Pulsed Dose Rate Brachytherapy

Primary Outcome Measures

Name	Time	Method
Increase the local control rate	24 months	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

Secondary Outcome Measures

Name	Time	Method
Maintain the cumulative rate grade III and IV complications below 6.5%	24 months
Relationship between the doses delivered to the target volume and local control	24 months
Relationship between the doses delivered to the critical organs and rate of grade III and IV complications	24 months

Trial Locations

Locations (9)

Centre Georges-François Leclerc; 🇫🇷 Dijon, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Centre Claudius Regaud; 🇫🇷 Toulouse, France

CHU de Besançon; 🇫🇷 Besancon, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHRU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-Nancy, France

Centre Léon Bérard; 🇫🇷 Lyon, France