- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119559
Circulating Tumor Cells as an Early Predictive head-and -Neck Squamous-cell Carcinoma (CIRCUTEC)
December 2, 2014 updated by: University Hospital, Montpellier
Assessment of Circulating Tumor Cells as an Early Predictive Marker of Response to a First Line Treatment Based on an Anti-Human Epidermal Growth Factor Receptor (HER), Cetuximab, in Patients With Inoperable Recurrent and/or Metastatic Head-and-neck Squamous-cell Carcinoma.
In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new cases/year.
During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients notably anti-HER molecules.
In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on an anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal Growth Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil (5FU): " Extreme protocol ".
However, no clinical or biological criteria predictive of drug efficacy have been reported yet.
Thus, the development of such a predictive factor is an urgent need in HNSCC at both the clinical and pharmacy-economic level, to propose the best personalized treatment.
One idea would be to enumerate and characterize the circulating tumor cells (CTC) which could give us an early evaluation of the therapeutic efficiency.
In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood.
The EPISPOT technology has been already evaluated in the breast and prostate cancer.Thus, the investigators would like for the first time to perform a prospective study on a cohort of patients treated following the Extreme protocol, with this technology, to assess the predictive value of CTC count.
The investigators will use the CellSearch® system as the reference test.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
This is a multi-centric prospective non randomized open labeled study performed on a cohort of patients with inoperable recurrent and/or metastatic HNSCC who will be treated, with a first line treatment based on an anti-Human Epidermal Growth Factor Receptor (HER), the Cetuximab.
Study Type
Interventional
Enrollment (Anticipated)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Alix Panabieres, PhD
- Phone Number: +33467330305
- Email: c-panabieres@chu-montpellier.fr
Study Locations
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-
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Montpellier, France, 34295
- Recruiting
- Department of Otorhinolaryngology, CHU Gui de Chauliac
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Contact:
- Renaud GARREL, MD
- Phone Number: +33467336920
- Email: r-garrel@chu-montpellier.fr
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Contact:
- Catherine PANABIERES, PhD
- Phone Number: +33467330305
- Email: c-panabieres@chu-montpellier.fr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 yo.
- Histologically or cytologically confirmed recurrent and/or metastatic Squamous Cell Carcinoma Head and Neck (SCCHN) (excluding nasopharyngeal carcinoma) not suitable for local therapy : surgery and/or radiotherapy ; or metastatic disease with or without primary evolving tumor.
- Target definable with Response Evaluation Tumors Criteria in Solid (RECIST) 1.1 criteria.
- WHO performance status 0,1 or 2.
- Life expectancy > 3 month at inclusion.
- Patient eligible for first line chemotherapy based on cisplatin (100 mg/m2 as a 1-hour intravenous (IV) infusion on day 1) or carboplatin (AUC 5 mg/ml.min by 1-hour IV infusion, day 1) and an infusion of 5-FU (1000 mg/m2/day for 4 days) every 3 weeks, with cetuximab (initial dose of 400 mg/m2 [2-hour IV infusion] followed by subsequent weekly doses of 250 mg/m2 [1-hour IV infusion], ending at least 1 hour before the start of chemotherapy).
- Consent form for participation signed.
Exclusion Criteria:
- Other chemotherapy protocol not involving platinum and cetuximab.
- Other proven synchronous evolving cancer.
- Evolving infectious disease or severe other disease preventing the patient from receiving treatment.
- Patient refusal.
- Patient unable to consent.
- Pregnant or breastfeeding, or premenopausal women not taking effective contraception.
- Current Participation to other clinical trial except experimental molecules.
- Vulnerable persons protected by law.
- People under guardianship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CTC assay, Cetuximab
Detection & characterization of viable CTC in the peripheral blood.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive value of the CTC on the Progression Free Survival
Time Frame: Duration study 2 years
|
The primary outcome aims to evaluate the predictive value of the early progression of the CTC performed with the EPISPOT assay on the progression free survival in a cohort of patients treated with protocol "Extreme".
The progression disease is assessed based on imagery techniques.
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Duration study 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prognostic value of the CTC at baseline (EPISPOT) and to compare for the first time the results with those obtained with the CellSearch system.
Time Frame: Duration study 2 years
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Duration study 2 years
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Prognostic value of the CTC at baseline (EPISPOT)
Time Frame: Duration study 2 years
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Duration study 2 years
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Predictive value of the early progression of CTC (EPISPOT) on the overall survival
Time Frame: Duration study 2 years
|
Duration study 2 years
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Compare for the first time the results with those obtained with the CellSearch® system
Time Frame: Duration study 2 years
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Duration study 2 years
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Evaluate the expression of EGFR in CTCs before and after administration of cetuximab (Erbitux) with both technologies and EPISPOT CellSearch ®
Time Frame: Duration study 2 years
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Duration study 2 years
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Evaluate the impact of the presence of epithelial-mesenchymal transition (EMT) marker on the prognosis
Time Frame: Duration study 2 years
|
Duration study 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: RENAUD GARREL, MD, CHU Gui de Chauliac
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garrel R, Mazel M, Perriard F, Vinches M, Cayrefourcq L, Guigay J, Digue L, Aubry K, Alfonsi M, Delord JP, Lallemant B, Even C, Daures JP, Landais P, Cupissol D, Alix-Panabieres C. Circulating Tumor Cells as a Prognostic Factor in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: The CIRCUTEC Prospective Study. Clin Chem. 2019 Oct;65(10):1267-1275. doi: 10.1373/clinchem.2019.305904. Epub 2019 Aug 6.
- Le Louedec F, Alix-Panabieres C, Lafont T, Allal BC, Garrel R, Digue L, Guigay J, Cupissol D, Delord JP, Lallemant B, Alfonsi M, Aubry K, Mazel M, Becher F, Perriard F, Chatelut E, Thomas F. Cetuximab pharmacokinetic/pharmacodynamics relationships in advanced head and neck carcinoma patients. Br J Clin Pharmacol. 2019 Jun;85(6):1357-1366. doi: 10.1111/bcp.13907. Epub 2019 Apr 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
March 28, 2014
First Submitted That Met QC Criteria
April 18, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
December 3, 2014
Last Update Submitted That Met QC Criteria
December 2, 2014
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplastic Processes
- Neoplasm Metastasis
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Neoplastic Cells, Circulating
Other Study ID Numbers
- 8825
- ID-RCB:2011-A01174-37 (Registry Identifier: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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