Clinical trial NCT01663753: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
measure: Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
city: Bordeaux
country: France
facility: Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
city: Bron
country: France
facility: Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
city: Dijon
country: France
facility: Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
city: Marseille
country: France
facility: Service de Gynécologie Obstétrique, Hôpital Nord
city: Montpellier
country: France
facility: Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Service de Radiothérapie, C.R.L.C. Val d'Aurelle
city: Nice
country: France
facility: Service de Gynécologie, Hôpital Archet II
city: Paris
country: France
facility: Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
city: Paris
country: France
facility: Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
city: Paris
country: France
facility: Service de Chirurgie Gynécologique, Institut Curie
city: Pierre-Bénite
country: France
facility: Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
city: Poitiers
country: France
facility: Service de Gynécologie Obstétrique, CHU la Milétrie
city: Rennes
country: France
facility: Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
city: Rennes
country: France
facility: Département des Radiations, Centre Eugène Marquis
city: Rouen
country: France
facility: Service de Chirurgie, Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
city: Saint-Etienne
country: France
facility: Service de Gynécologie Obstétrique, CHU St-Etienne
city: Saint-Herblain
country: France
facility: Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
city: Saint-Priest en Jarez
country: France
facility: Département de Radiothérapie, Institut de Cancérologie de la Loire
city: Vandoeuvre lès Nancy
country: France
facility: Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
city: Vandoeuvre-lès-Nancy
country: France
facility: Service de Médecine Nucléaire, Hôpital Brabois
Study officials:
affiliation: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
name: GOLFIER François, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: