Cervical CancerTEP-CurieNCT03315351
Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer
A study testing Brachytherapy and PET-scan in people with Cervical Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Brachytherapy and PET-scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2017to 11 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan
Read the 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
- Being tested
- Brachytherapy, PET-scan
- Keywords
- PET-scan, Brachytherapy, Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyProcedure or surgery
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-scanOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study Procedure | Experimental | Brachytherapy. PET-scan. Receives: Procedure: Brachytherapy; Other: PET-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
Secondary outcomes (5)
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
Measured: 4 months
Assessment of the HR-CTV coverage
Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone
Measured: 4 months
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
Measured: 4 months
Time needed to design the different alternative treatment plans
Measured: 4 months
Toxicity linked to the standard treatment driven by RMI only
Graded according to the NCI CTCAE v4. scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start3 Nov 2017
- Primary completion26 Oct 2018
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abel CORDOBA, MD, Principal investigator, Centre oscar Lambret de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315351
- Sponsor's protocol ID
- TEP-Curie-1702
- Other IDs
- 2017-A01888-45
- Acronym
- TEP-Curie
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2017
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03315351
- Acronym / sponsor ID
- TEP-Curie / TEP-Curie-1702
- Conditions
- Cervical Cancer
- Keywords
- PET-scan, Brachytherapy, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Procedure | Experimental | Procedure: Brachytherapy, Other: PET-scanBrachytherapy. PET-scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyBefore 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 | Procedure or surgery | Study Procedure |
| PET-scanThe 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 | Other | Study Procedure |
Primary outcome
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams
Time frame: 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 possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)
Time frame: 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
Time frame: 4 months
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
Time frame: 4 months
Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans
5 secondary outcomes
Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition
Time frame: 4 months
Assessment of the HR-CTV coverage
Time frame: 4 months
Assessment of the dose received by the neighboring target organs
Time frame: 4 months
Time needed to design the different alternative treatment plans
Time frame: 4 months
Toxicity linked to the standard treatment driven by RMI only
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abel CORDOBA, MD principal investigator
Centre oscar Lambret de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and PET-scan in people with Cervical Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.