Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG-PET | Experimental | The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG-PET | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks | |
| Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GOLFIER François, MD, PhD | Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin | Angers | 49933 | France | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 8 weeks |
| Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux |
| Bordeaux |
| 33076 |
| France |
| Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon | Bron | 69677 | France |
| Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon | Lyon | 69004 | France |
| Service de Gynécologie Obstétrique, Hôpital Nord | Marseille | 13915 | France |
| Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Service de Radiothérapie, C.R.L.C. Val d'Aurelle | Montpellier | 34298 | France |
| Service de Gynécologie, Hôpital Archet II | Nice | 06200 | France |
| Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP | Paris | 75015 | France |
| Service de Gynécologie Obstétrique, Hôpital Tenon, APHP | Paris | 75020 | France |
| Service de Chirurgie Gynécologique, Institut Curie | Paris | 75248 | France |
| Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69310 | France |
| Service de Gynécologie Obstétrique, CHU la Milétrie | Poitiers | 86021 | France |
| Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud | Rennes | 35000 | France |
| Département des Radiations, Centre Eugène Marquis | Rennes | 35042 | France |
| Service de Chirurgie, Centre Henri Becquerel | Rouen | 76038 | France |
| Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin | Saint-Cloud | 92210 | France |
| Service de Gynécologie Obstétrique, CHU St-Etienne | Saint-Etienne | 42055 | France |
| Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique | Saint-Herblain | 44805 | France |
| Département de Radiothérapie, Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | 42271 | France |
| Service de Médecine Nucléaire, Hôpital Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided