Cancer of the Uterine Cervix Clinical Trial
— ERRICCOfficial 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
| NCT number | NCT01663753 |
| Other study ID # | 2011.670/13 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2012 |
| Est. completion date | August 2018 |
| Verified date | January 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 146 |
| Est. completion date | August 2018 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 Chirurgie Gynécologique, Institut Curie | Paris | |
| France | Service de Gynécologie Obstétrique, Hôpital Tenon, APHP | Paris | |
| France | Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP | 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 | Département des Radiations, Centre Eugène Marquis | Rennes | |
| France | Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | ||
| Secondary | Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy | 8 weeks |
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