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

NCT ID: NCT02119559

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Head-and-neck Squamous-cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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CTC assay, Cetuximab

Detection \& characterization of viable CTC in the peripheral blood.

Group Type OTHER

Blood analysis by EPISPOT and CellSearch®

Intervention Type OTHER

Interventions

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Blood analysis by EPISPOT and CellSearch®

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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RENAUD GARREL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU GUI DE CHAULIAC

Locations

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Department of Otorhinolaryngology, CHU Gui de Chauliac

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine Alix Panabieres, PhD

Role: CONTACT

[email protected]
+33467330305

Facility Contacts

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Renaud GARREL, MD

Role: primary

[email protected]
+33467336920

Catherine PANABIERES, PhD

Role: backup

[email protected]
+33467330305

References

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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.

Reference Type DERIVED
PMID: 31387885 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30811063 (View on PubMed)

Other Identifiers

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ID-RCB:2011-A01174-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

8825

Identifier Type: -

Identifier Source: org_study_id