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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)

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ClinicalTrials.gov Identifier: NCT01663753
Recruitment Status : Active, not recruiting
First Posted : August 13, 2012
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cancer of the Uterine Cervix Device: 18F-FDG-PET Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663753


Locations
France
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, France, 49933
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
Bordeaux, France, 33076
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France, 69677
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69004
Service de Gynécologie Obstétrique, Hôpital Nord
Marseille, France, 13915
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Service de Radiothérapie, C.R.L.C. Val d'Aurelle
Montpellier, France, 34298
Service de Gynécologie, Hôpital Archet II
Nice, France, 06200
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
Paris, France, 75015
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
Paris, France, 75020
Service de Chirurgie Gynécologique, Institut Curie
Paris, France, 75248
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69310
Service de Gynécologie Obstétrique, CHU la Milétrie
Poitiers, France, 86021
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
Rennes, France, 35000
Département des Radiations, Centre Eugène Marquis
Rennes, France, 35042
Service de Chirurgie, Centre Henri Becquerel
Rouen, France, 76038
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
Saint-Cloud, France, 92210
Service de Gynécologie Obstétrique, CHU St-Etienne
Saint-Etienne, France, 42055
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
Saint-Herblain, France, 44805
Département de Radiothérapie, Institut de Cancérologie de la Loire
Saint-Priest en Jarez, France, 42271
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
Vandoeuvre lès Nancy, France, 54519
Service de Médecine Nucléaire, Hôpital Brabois
Vandoeuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: GOLFIER François, MD, PhD Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01663753     History of Changes
Other Study ID Numbers: 2011.670/13
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by Hospices Civils de Lyon:
2-fluoro-2-deoxy-d-glucose-positron emission tomography
Positron emission tomography
Magnetic resonance imaging
Diffusion weighted MRI
Squamous-cell cervical carcinoma
Sensitivity

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Body Weight
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action