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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)

Primary Purpose

Cancer of the Uterine Cervix

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-FDG-PET
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer of the Uterine Cervix focused on measuring 2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
  • Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
  • Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
  • Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
  • Centre Oscar Lambret
  • Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
  • Service de Gynécologie Obstétrique, Hôpital Nord
  • Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
  • Service de Radiothérapie, C.R.L.C. Val d'Aurelle
  • Service de Gynécologie, Hôpital Archet II
  • Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
  • Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
  • Service de Chirurgie Gynécologique, Institut Curie
  • Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
  • Service de Gynécologie Obstétrique, CHU la Milétrie
  • Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
  • Département des Radiations, Centre Eugène Marquis
  • Service de Chirurgie, Centre Henri Becquerel
  • Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
  • Service de Gynécologie Obstétrique, CHU St-Etienne
  • Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
  • Département de Radiothérapie, Institut de Cancérologie de la Loire
  • Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
  • Service de Médecine Nucléaire, Hôpital Brabois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FDG-PET

Arm Description

The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)

Outcomes

Primary Outcome Measures

Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
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.

Secondary Outcome Measures

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
Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy

Full Information

First Posted
August 9, 2012
Last Updated
January 4, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01663753
Brief Title
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
Acronym
ERRICC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Uterine Cervix
Keywords
2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG-PET
Arm Type
Experimental
Arm Description
The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)
Intervention Type
Device
Intervention Name(s)
18F-FDG-PET
Primary Outcome Measure Information:
Title
Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GOLFIER François, MD, PhD
Organizational Affiliation
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Service de Gynécologie Obstétrique, Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Service de Radiothérapie, C.R.L.C. Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Service de Gynécologie, Hôpital Archet II
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Service de Chirurgie Gynécologique, Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Service de Gynécologie Obstétrique, CHU la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Département des Radiations, Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Service de Chirurgie, Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Service de Gynécologie Obstétrique, CHU St-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Département de Radiothérapie, Institut de Cancérologie de la Loire
City
Saint-Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Service de Médecine Nucléaire, Hôpital Brabois
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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