Cervical Cancer
Conditions
Keywords
PET-scan, Brachytherapy, Cervical Cancer
Brief summary
Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan
Detailed description
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
Interventions
PROCEDUREBrachytherapy
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
OTHERPET-scan
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
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams | 4 months | Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam |
| Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume) | 4 months | 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 |
| Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer | 4 months | Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format |
| Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility | 4 months | Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity linked to the standard treatment driven by RMI only | 4 months | Graded according to the NCI CTCAE v4. scale |
| Time needed to design the different alternative treatment plans | 4 months | — |
| Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition | 4 months | Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone |
| Assessment of the HR-CTV coverage | 4 months | Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone |
| Assessment of the dose received by the neighboring target organs | 4 months | Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAbel CORDOBA, MD
Centre oscar Lambret de Lille
Outcome results
None listed