Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy (ERRICC)

January 4, 2019 updated by: Hospices Civils de Lyon

Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.

Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

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
        • Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
      • Bordeaux, France, 33076
        • Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
      • Bron, France, 69677
        • Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
      • Dijon, France, 21079
        • Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69004
        • Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
      • Marseille, France, 13915
        • Service de Gynécologie Obstétrique, Hôpital Nord
      • Montpellier, France, 34295
        • Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
      • Montpellier, France, 34298
        • Service de Radiothérapie, C.R.L.C. Val d'Aurelle
      • Nice, France, 06200
        • Service de Gynécologie, Hôpital Archet II
      • Paris, France, 75015
        • Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
      • Paris, France, 75020
        • Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
      • Paris, France, 75248
        • Service de Chirurgie Gynécologique, Institut Curie
      • Pierre-Bénite, France, 69310
        • Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
      • Poitiers, France, 86021
        • Service de Gynécologie Obstétrique, CHU la Milétrie
      • Rennes, France, 35000
        • Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
      • Rennes, France, 35042
        • Département des Radiations, Centre Eugène Marquis
      • Rouen, France, 76038
        • Service de Chirurgie, Centre Henri Becquerel
      • Saint-Cloud, France, 92210
        • Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
      • Saint-Etienne, France, 42055
        • Service de Gynécologie Obstétrique, CHU St-Etienne
      • Saint-Herblain, France, 44805
        • Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
      • Saint-Priest en Jarez, France, 42271
        • Département de Radiothérapie, Institut de Cancérologie de la Loire
      • Vandoeuvre lès Nancy, France, 54519
        • Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
      • Vandoeuvre-lès-Nancy, France, 54511
        • Service de Médecine Nucléaire, Hôpital Brabois

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:

  • Female patients 18 years of age or older
  • Biopsy-confirmed cervical squamous-cell carcinomas
  • Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas
  • No spread to lumbo-aortic lymph nodes
  • No prior pelvic radiotherapy
  • No prior cancer treatment
  • WHO Performance status less than or equal to 1
  • Beneficiary of a health insurance
  • Must provide her signed and informed consent

Exclusion Criteria:

  • Reccurent or Metastasized cancer
  • History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)
  • Any contraindication to MRI
  • Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients
  • Pregnant or breast feeding patients
  • Participation in any other clinical trial that could interfere with the study results
  • Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FDG-PET
The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)
Device: 18F-FDG-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time Frame: 8 weeks
A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time Frame: 8 weeks
8 weeks
Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: GOLFIER François, MD, PhD, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

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)

March 1, 2012

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.670/13

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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