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

Cervical Cancer Clinical Trial

— TEP-Curie  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315351
• Other study ID #: TEP-Curie-1702
• Secondary ID: 2017-A01888-45
• Status: Completed
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: March 11, 2019

Study information

• Verified date: July 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 11, 2019
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Brachytherapy
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

Other:
• PET-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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams	Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam	4 months
Primary	Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)	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	4 months
Primary	Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer	Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format	4 months
Primary	Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility	Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans	4 months
Secondary	Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition	Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone	4 months
Secondary	Assessment of the HR-CTV coverage	Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone	4 months
Secondary	Assessment of the dose received by the neighboring target organs	Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone	4 months
Secondary	Time needed to design the different alternative treatment plans		4 months
Secondary	Toxicity linked to the standard treatment driven by RMI only	Graded according to the NCI CTCAE v4. scale	4 months