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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01663753
First received: August 9, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 11 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 Intervention
Squamous-cell Cervical Carcinoma Stage IB2 to IIB Without Spread to Lymph Nodes or Metastasis
Device: 18F-FDG-PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-FDG-PET
The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)
Device: 18F-FDG-PET

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663753

Contacts
Contact: François GOLFIER, MD, PhD 478 86 41 79 ext +33 francois.golfier@chu-lyon.fr
Contact: Anne-Marie SCHOTT, MD, PhD 472 11 51 65 ext +33 anne-marie.schott-pethelaz@chu-lyon.fr

Locations
France
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin Recruiting
Angers, France, 49933
Contact: Sylvie GIRAULT, MD         
Principal Investigator: Sylvie GIRAULT, MD         
Sub-Investigator: Nathalie MESGOUEZ-NEBOUT, MD         
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Jean-Luc BRUN, MD, PhD         
Principal Investigator: Jean-Luc BRUN, MD, PhD         
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Gery LAMBLIN, MD, PhD         
Principal Investigator: Gery LAMBLIN, MD         
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc Recruiting
Dijon, France, 21079
Contact: Charles COUTANT, MD         
Principal Investigator: Charles COUTANT, MD         
Sub-Investigator: Etienne MARTIN, MD         
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Gil DUBERNARD, MD, PhD         
Principal Investigator: Gil DUBERNARD, MD, PhD         
Service de Gynécologie Obstétrique, Hôpital Nord Recruiting
Marseille, France, 13915
Contact: Léon BOUBLI, MD         
Principal Investigator: Léon BOUBLI, MD         
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Gauthier RATHAT, MD         
Principal Investigator: Gauthier RATHAT, MD         
Service de Radiothérapie, C.R.L.C. Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Christine KERR, MD         
Principal Investigator: Christine KERR, MD         
Service de Gynécologie, Hôpital Archet II Recruiting
Nice, France, 06200
Contact: Jérôme DELOTTE, MD         
Principal Investigator: Jérôme DELOTTE, MD         
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP Recruiting
Paris, France, 75020
Contact: Emile DARAI, MD, PhD         
Principal Investigator: Emile DARAI, MD, PhD         
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP Recruiting
Paris, France, 75015
Contact: Fabrice LECURU, MD, PhD         
Principal Investigator: Fabrice LECURU, MD, PhD         
Service de Chirurgie Gynécologique, Institut Curie Recruiting
Paris, France, 75248
Contact: Virginie FOURCHOTTE, MD         
Principal Investigator: Virginie FOURCHOTTE, MD         
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Recruiting
Pierre-Bénite, France, 69310
Contact: François GOLFIER, MD, PhD    478 86 41 79 ext +33    francois.golfier@chu-lyon.fr   
Principal Investigator: François GOLFIER, MD, PhD         
Sub-Investigator: Daniel RAUDRANT, MD, PhD         
Service de Gynécologie Obstétrique, CHU la Milétrie Recruiting
Poitiers, France, 86021
Contact: Xavier FRITEL, MD         
Principal Investigator: Xavier FRITEL, MD         
Sub-Investigator: Antoine BERGER, MD         
Département des Radiations, Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Julie LESEUR, MD         
Principal Investigator: Julie LESEUR, MD         
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud Recruiting
Rennes, France, 35000
Contact: Jean LEVEQUE, MD, PhD         
Principal Investigator: Jean LEVEQUE, MD, PhD         
Service de Chirurgie, Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Frédérique FORESTIER-LEBRETON, MD         
Principal Investigator: Frédérique FORESTIER-LEBRETON, MD         
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin Recruiting
Saint-Cloud, France, 92210
Contact: Roman ROUZIER, MD         
Principal Investigator: Roman ROUZIER, MD         
Service de Gynécologie Obstétrique, CHU St-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Céline CHAULEUR, MD         
Principal Investigator: Céline CHAULEUR, MD         
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique Recruiting
Saint-Herblain, France, 44805
Contact: Caroline ROUSSEAU, MD, PhD         
Principal Investigator: Caroline ROUSSEAU, MD, PhD         
Département de Radiothérapie, Institut de Cancérologie de la Loire Recruiting
Saint-Priest en Jarez, France, 42271
Contact: Nicolas MAGNE, MD         
Principal Investigator: Nicolas MAGNE, MD         
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre lès Nancy, France, 54519
Contact: Frédéric MARCHAL, MD         
Principal Investigator: Frédéric MARCHAL, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: GOLFIER François, MD, PhD Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01663753     History of Changes
Other Study ID Numbers: 2011.670/13
Study First Received: August 9, 2012
Last Updated: January 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Neoplasm Metastasis
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014