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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Brachytherapy; Other: PET-scan

• Registration Number: NCT03315351
• Lead Sponsor: Centre Oscar Lambret

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

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Study Start: 2017-11-03
• Primary Completion: 2018-10-26
• Study Completion: 2019-03-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Procedure	PET-scan	Brachytherapy. PET-scan.
Study Procedure	Brachytherapy	Brachytherapy. PET-scan.

Primary Outcome Measures

Name	Time	Method
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 contouring possibility	4 months	Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans
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

Secondary Outcome Measures

Name	Time	Method
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 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
Time needed to design the different alternative treatment plans	4 months
Toxicity linked to the standard treatment driven by RMI only	4 months	Graded according to the NCI CTCAE v4. scale
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

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France