Spots Global Cancer Trial Database for 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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Trial Identification
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
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 ID: NCT01663753
Conditions
Interventions
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin, Angers, , France
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux, Bordeaux, , France
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, , France
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, , France
Service de Gynécologie Obstétrique, Hôpital Nord, Marseille, , France
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve, Montpellier, , France
Service de Radiothérapie, C.R.L.C. Val d'Aurelle, Montpellier, , France
Service de Gynécologie, Hôpital Archet II, Nice, , France
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP, Paris, , France
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP, Paris, , France
Service de Chirurgie Gynécologique, Institut Curie, Paris, , France
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, , France
Service de Gynécologie Obstétrique, CHU la Milétrie, Poitiers, , France
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud, Rennes, , France
Département des Radiations, Centre Eugène Marquis, Rennes, , France
Service de Chirurgie, Centre Henri Becquerel, Rouen, , France
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin, Saint-Cloud, , France
Service de Gynécologie Obstétrique, CHU St-Etienne, Saint-Etienne, , France
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique, Saint-Herblain, , France
Département de Radiothérapie, Institut de Cancérologie de la Loire, Saint-Priest en Jarez, , France
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine, Vandoeuvre lès Nancy, , France
Service de Médecine Nucléaire, Hôpital Brabois, Vandoeuvre-lès-Nancy, , France
Contact Details
Name: GOLFIER François, MD, PhD
Affiliation: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Role: PRINCIPAL_INVESTIGATOR
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