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

March 6, 2020 updated by: Institut de Cancérologie de Lorraine

A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • CHU de Besançon
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Dijon, France, 21079
        • Centre Georges-Francois Leclerc
      • Lyon, France, 69373
        • Centre Leon Berard
      • Montpellier, France, 34298
        • Centre Val d'Aurelle
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Toulouse, France, 31052
        • Centre Claudius Regaud
      • Tours, France, 37044
        • CHRU Tours - Hôpital Bretonneau
      • Vandoeuvre-les-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM A
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy
Radiation: External Beam Radiation Therapy
45 Gy pelvis / 25 fr
Other Names:
  • EBRT
Radiation: PDR Brachytherapy
1 puls/hour ; 12 Gy / day
Drug: Cisplatin
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
Other Names:
  • CDDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase the local control rate
Time Frame: 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
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: PEIFFERT Didier, Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2011

Primary Completion (Actual)

February 10, 2014

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00235-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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