Status:
COMPLETED
Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03315351
Start Date
November 3 2017
End Date
March 11 2019
Last Update
July 10 2019
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020