Clinical trial NCT03315351: Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer
Official title: Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: PET-scan
Brachytherapy
Cervical Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams
timeFrame: 4 months
measure: Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)
timeFrame: 4 months
measure: Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer
timeFrame: 4 months
measure: Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility
timeFrame: 4 months
Secondary outcomes:
measure: Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition
timeFrame: 4 months
measure: Assessment of the HR-CTV coverage
timeFrame: 4 months
measure: Assessment of the dose received by the neighboring target organs
timeFrame: 4 months
measure: Time needed to design the different alternative treatment plans
timeFrame: 4 months
measure: Toxicity linked to the standard treatment driven by RMI only
timeFrame: 4 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre oscar Lambret de Lille
name: Abel CORDOBA, MD
role: PRINCIPAL_INVESTIGATOR
References: