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Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer (TEP-Curie)

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brachytherapy
PET-scan
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer focused on measuring PET-scan, Brachytherapy, Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar Lambret

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Procedure

Arm Description

Brachytherapy. PET-scan.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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
Assessment of the HR-CTV coverage
Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone
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
Time needed to design the different alternative treatment plans
Toxicity linked to the standard treatment driven by RMI only
Graded according to the NCI CTCAE v4. scale

Full Information

First Posted
September 25, 2017
Last Updated
July 9, 2019
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT03315351
Brief Title
Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
PET-scan, Brachytherapy, Cervical Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abel CORDOBA, MD
Organizational Affiliation
Centre oscar Lambret de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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