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

NCT ID: NCT03315351

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2019-03-11

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

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Procedure

Brachytherapy. PET-scan.

Group Type: EXPERIMENTAL

Brachytherapy

Intervention Type: PROCEDURE

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

PET-scan

Intervention Type: OTHER

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abel CORDOBA, MD

Role: PRINCIPAL_INVESTIGATOR

Centre oscar Lambret de Lille

Locations

Centre Oscar Lambret

Lille, , France

Countries

France

Other Identifiers

2017-A01888-45

Identifier Type: OTHER

Identifier Source: secondary_id

TEP-Curie-1702

Identifier Type: -

Identifier Source: org_study_id