Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer (TEP-Curie)

Centre Oscar Lambret

Status

Completed

Conditions

Cervical Cancer

Treatments

Other: PET-scan

Procedure: Brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

TEP-Curie-1702

2017-A01888-45 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

14 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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