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.
Verified August 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01663753
First received: August 9, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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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
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 Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux | Not yet 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: Patrice MATHEVET, MD, PhD | |
| Principal Investigator: Patrice MATHEVET | |
| 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, Hôpital Européen Georges Pompidou, APHP | Not yet recruiting |
| Paris, France, 75015 | |
| Contact: Fabrice LECURU, MD, PhD | |
| Principal Investigator: Fabrice LECURU, MD, PhD | |
| Service de Radiothérapie-Oncologie, Hôpital Européen Georges Pompidou, APHP | Not yet recruiting |
| Paris, France, 75015 | |
| Contact: Catherine DURDUX, MD | |
| Principal Investigator: Catherine DURDUX, MD | |
| Service de Gynécologie Obstétrique, Hôpital Tenon, APHP | Not yet recruiting |
| Paris, France, 75020 | |
| Contact: Emile DARAI, MD, PhD | |
| Principal Investigator: Emile DARAI, MD, PhD | |
| Service de Radiothérapie-Oncologie, Hôpital Tenon, APHP | Not yet recruiting |
| Paris, France, 75020 | |
| Contact: Emmanuel TOUBOUL, MD, PhD | |
| Principal Investigator: Emmanuel TOUBOUL, MD, PhD | |
| Département de Radiothérapie Oncologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Recruiting |
| Pierre-Bénite, France, 69310 | |
| Contact: Olivier CHAPET, MD, PhD | |
| Principal Investigator: Olivier CHAPET, MD, PhD | |
| 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 Anne de Bretagne Hôpital Sud | Not yet recruiting |
| Rennes, France, 35000 | |
| Contact: Jean LEVEQUE, MD, PhD | |
| Principal Investigator: Jean LEVEQUE, MD, PhD | |
| Département des Radiations, Centre Eugène Marquis | Not yet recruiting |
| Rennes, France, 35042 | |
| Contact: Julie LESEUR, MD | |
| Principal Investigator: Julie LESEUR, MD | |
| Service de Gynécologie Obstétrique, CHU St-Etienne | Not yet recruiting |
| Saint-Etienne, France, 42055 | |
| Contact: Céline CHAULEUR, MD | |
| Principal Investigator: Céline CHAULEUR, MD | |
| Service de Radiothérapie-Oncologie, Centre René Gauducheau, CRLCC Nantes Atlantique | Not yet recruiting |
| Saint-Herblain, France, 44805 | |
| Contact: Maud AUMONT, MD | |
| Principal Investigator: Maud AUMONT | |
| Servce de Gynécologie, Centre René Gauducheau, CRLCC Nantes Atlantique | Not yet recruiting |
| Saint-Herblain, France, 44805 | |
| Contact: Jean Marc CLASSE, MD, PhD | |
| Principal Investigator: Jean Marc CLASSE, MD, PhD | |
| Département de Radiothérapie, Institut de Cancérologie de la Loire | Not yet recruiting |
| Saint-Priest en Jarez, France, 42271 | |
| Contact: Nicolas MAGNE, MD | |
| Principal Investigator: Nicolas MAGNE, MD | |
| Service de Gynécologie, Institut Gustave Roussy | Not yet recruiting |
| Villejuif, France, 94800 | |
| Contact: Philippe MORICE, MD, PhD | |
| Principal Investigator: Philippe MORICE, MD, PhD | |
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: | August 9, 2012 |
| 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 May 22, 2013