Cancer of the Uterine CervixERRICCNCT01663753
Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy
A study testing 18F-FDG-PET in people with Cancer of the Uterine Cervix, run by Hospices Civils de Lyon at 24 sites in France.
Trial summary
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Uterine Cervix
- What is being tested?
- 18F-FDG-PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 24 sitesFrance
- Study dates
- Mar 2012to Aug 2018
- 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
- Female patients 18 years of age or older
- Biopsy-confirmed cervical squamous-cell carcinomas
- Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas
- No spread to lumbo-aortic lymph nodes
- No prior pelvic radiotherapy
- No prior cancer treatment
Show all 9Show fewer
- WHO Performance status less than or equal to 1
- Beneficiary of a health insurance
- Must provide her signed and informed consent
Who cannot join
- Reccurent or Metastasized cancer
- History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)
- Any contraindication to MRI
- Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients
- Pregnant or breast feeding patients
- Participation in any other clinical trial that could interfere with the study results
- Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, 49933
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
Bordeaux, 33076
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69677
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Service de Gynécologie Obstétrique, Hôpital Nord
Marseille, 13915
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
Montpellier, 34295
Service de Radiothérapie, C.R.L.C. Val d'Aurelle
Montpellier, 34298
Service de Gynécologie, Hôpital Archet II
Nice, 06200
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
Paris, 75015
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
Paris, 75020
Service de Chirurgie Gynécologique, Institut Curie
Paris, 75248
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
Service de Gynécologie Obstétrique, CHU la Milétrie
Poitiers, 86021
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
Rennes, 35000
Département des Radiations, Centre Eugène Marquis
Rennes, 35042
Service de Chirurgie, Centre Henri Becquerel
Rouen, 76038
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
Saint-Cloud, 92210
Service de Gynécologie Obstétrique, CHU St-Etienne
Saint-Etienne, 42055
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
Saint-Herblain, 44805
Département de Radiothérapie, Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
Service de Médecine Nucléaire, Hôpital Brabois
Vandœuvre-lès-Nancy, 54511
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.
Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.
Read more
Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.
Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.
- Conditions
- Cancer of the Uterine Cervix
- Being tested
- 18F-FDG-PET
- Keywords
- 2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity
- Medical subject headings
- Uterine Cervical Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG-PETDevice
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG-PET | Experimental | The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion) Receives: Device: 18F-FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.
Measured: 8 weeks
Secondary outcomes (2)
Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Measured: 8 weeks
Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Uterine CervixStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GOLFIER François, MD, PhD, Principal investigator, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663753
- Sponsor's protocol ID
- 2011.670/13
- Acronym
- ERRICC
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2012
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy
- ClinicalTrials.gov ID
- NCT01663753
- Acronym / sponsor ID
- ERRICC / 2011.670/13
- Conditions
- Cancer of the Uterine Cervix
- Keywords
- 2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Aug 2012 (estimated)
- 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.
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.
Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.
Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.
Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG-PET | Experimental | Device: 18F-FDG-PETThe 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients 18 years of age or older
- Biopsy-confirmed cervical squamous-cell carcinomas
- Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas
- No spread to lumbo-aortic lymph nodes
- No prior pelvic radiotherapy
Key exclusion criteria (7 listed)
- Reccurent or Metastasized cancer
- History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)
- Any contraindication to MRI
- Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients
- Pregnant or breast feeding patients
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 |
|---|---|---|
| 18F-FDG-PET | Device | 18F-FDG-PET |
Primary outcome
Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time frame: 8 weeks
A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.
2 secondary outcomes
Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time frame: 8 weeks
Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
Time frame: 8 weeks
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 7 Jan 2019.
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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.
GOLFIER François, MD, PhD principal investigator
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG-PET in people with Cancer of the Uterine Cervix, run by Hospices Civils de Lyon at 24 sites 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 9 inclusion and 7 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy (time frame: 8 weeks). 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 7 Jan 2019.