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Metastatic Head-and-neck Squamous-cell CarcinomaCIRCUTECNCT02119559

Circulating Tumor Cells as an Early Predictive head-and -Neck Squamous-cell Carcinoma

A study testing Blood analysis by EPISPOT and CellSearch® in people with Metastatic Head-and-neck Squamous-cell Carcinoma, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood analysis by EPISPOT and CellSearch®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteFrance
Study dates
Sep 2012to Mar 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Current Participation to other clinical trial except experimental molecules.
  • Vulnerable persons protected by law.
  • People under guardianship

Trial locations and contacts

1 site in 1 country.

Catherine Alix Panabieres, PhD contact

+33467330305

c-panabieres@chu-montpellier.fr

France1 site, 1 recruiting

  • Department of Otorhinolaryngology, CHU Gui de Chauliac

    Montpellier, 34295

    Renaud GARREL, MD, +33467336920, r-garrel@chu-montpellier.fr

    Catherine PANABIERES, PhD, +33467330305, c-panabieres@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Blood analysis by EPISPOT and CellSearch®
Keywords
Circulating Tumor Cells, Treatment Efficiency, Biomarker
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood analysis by EPISPOT and CellSearch®Other

    Also called A counting of CTC using three technologies: EPISPOT, CellSearch®, flow cytometer sorter/analyzer.

Study groups in NCT02119559
Study groupRoleWhat they receive
CTC assay, CetuximabOtherDetection \& characterization of viable CTC in the peripheral blood.
Receives: Other: Blood analysis by EPISPOT and CellSearch®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predictive value of the CTC on the Progression Free Survival

    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.

    Measured: Duration study 2 years

Secondary outcomes (6)

  1. Prognostic value of the CTC at baseline (EPISPOT) and to compare for the first time the results with those obtained with the CellSearch system.

    Measured: Duration study 2 years

  2. Prognostic value of the CTC at baseline (EPISPOT)

    Measured: Duration study 2 years

  3. Predictive value of the early progression of CTC (EPISPOT) on the overall survival

    Measured: Duration study 2 years

  4. Compare for the first time the results with those obtained with the CellSearch® system

    Measured: Duration study 2 years

  5. Evaluate the expression of EGFR in CTCs before and after administration of cetuximab (Erbitux) with both technologies and EPISPOT CellSearch ®

    Measured: Duration study 2 years

  6. Evaluate the impact of the presence of epithelial-mesenchymal transition (EMT) marker on the prognosis

    Measured: Duration study 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02119559
Sponsor's protocol ID
8825
Other IDs
ID-RCB:2011-A01174-37
Acronym
CIRCUTEC
Status last verified
Sep 2012
First submitted
28 Mar 2014
Last updated
3 Dec 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 31387885

  • 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.

    PubMed 30811063

Questions about this trial

What is this clinical trial studying?

A study testing Blood analysis by EPISPOT and CellSearch® in people with Metastatic Head-and-neck Squamous-cell Carcinoma, run by University Hospital, Montpellier 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Dec 2014. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Catherine Alix Panabieres, PhD (+33467330305, c-panabieres@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predictive value of the CTC on the Progression Free Survival (time frame: Duration study 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119559, which also lists 2 linked publications.

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 3 Dec 2014.

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