Adaptative Radiotherapy for Locally Advanced Cervical Cancer (ARCOL)

September 1, 2022 updated by: Center Eugene Marquis

Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

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
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest
      • Caen, France, 14000
        • Centre Francois Baclesse
      • Dijon, France, 21034
        • CLCC Georges François Leclerc
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • Centre Léon Bérard
      • Nantes, France, 44805
        • Centre Rene Gauducheau
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Tours, France, 37044
        • CHU de Tours
      • Vandoeuvre Les Nancy, France, 54500
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Gustave Roussy

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:

  • Cervix carcinoma proved by histology
  • According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
  • Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
  • Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
  • Older than 18 years
  • Good general status, World Health Organization less or equal to 1
  • Signed informed consent

Exclusion Criteria:

  • History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
  • History of pelvic irradiation
  • Simultaneous participation to another research that could interfere with the study results
  • Pregnant or breastfeeding patient
  • Patient under tutor or guardian
  • Patient not able to respect medical follow-up for geographical, social or psychological reasons
  • Not affiliated to a system of French social security

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptative Treatment plans
A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day.
Other: Adaptative treatment plan
Each patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an "intermediate" one, one to a full bladder.
Radiation: External radiotherapy
At the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
Time Frame: 3 months after end of radio-chemotherapy treatment
3 months after end of radio-chemotherapy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03
Time Frame: 3 months after end of radio-chemotherapy treatment
3 months after end of radio-chemotherapy treatment

Collaborators and Investigators

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

Sponsor

Center Eugene Marquis

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)

April 5, 2017

Primary Completion (Actual)

May 27, 2020

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-02-45-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not authorized in France

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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