Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer

Study Overview
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Brief Summary
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Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan

Detailed Description
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The study will proceed as follow: Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy). additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy) 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters

Official Title
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Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Brachytherapy
* Other: PET-scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering from a cervical cancer: squamous-cell carcinoma or adenocarcinoma histologically proven classified from FIGO 2009 IB2 to IVA stage Age ≥ 18 years old Examination by PET-scan and pelvic RMI realized at diagnosis Examination by negative PET-scan remotely closed and at lymph node level Surgical lymphadenectomy negative at paraaortic level Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done Scheduled curative treatment by brachytherapy driven by RMI Affiliation to the National Social Security System With informed and signed consent before any procedure specific to the study Exclusion Criteria: Performance status of WHO score > 2 Other histology than squamous cell carcinoma or adenocarcinoma Metastatic patient or paraaortic node positive Adjuvant radiochemotherapy after the first surgery Dementia or psychiatric history Kidney failure Diabet Chronic inflammatory bowel disease Pelvic and/or vesicoureteral surgery history Pelvic irradiation history Other active neoplasia or < 5 years old, except for basocellular carcinoma that can be locally treated Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity. Treatment with palliative intent Pregnant or breastfeeding women Patient Under guardianship or tutorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Procedure<br>Brachytherapy. PET-scan. | Procedure: Brachytherapy<br>* Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized. The brachytherapy include a pulsating flow treatment driven by RMI and CT-scan<br>Other: PET-scan<br>* The patient will undergo 2 PET-scan during the clinical trial: the first one is additional to the brachytherapy the second one is realized 4 months after the brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of TEP-Curie (Brachytherapy driven by PET-scan) in terms of realized exams | Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam | 4 months | 
| Feasibility of TEP-Curie (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume) | Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET | 4 months | 
| Feasibility of TEP-Curie (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer | Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format | 4 months | 
| Feasibility of TEP-Curie (Brachytherapy driven by PET-scan) regarding the contouring possibility | Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the TEP-Curie (Brachytherapy driven by PET-scan) on target volume definition | Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone | 4 months | 
| Assessment of the HR-CTV coverage | Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone | 4 months | 
| Assessment of the dose received by the neighboring target organs | Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone | 4 months | 
| Time needed to design the different alternative treatment plans |  | 4 months | 
| Toxicity linked to the standard treatment driven by RMI only | Graded according to the NCI CTCAE v4. scale | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, PET-scan, Brachytherapy