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

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ClinicalTrials.gov Identifier: NCT02119559
Recruitment Status : Unknown
Verified September 2012 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Metastatic Head-and-neck Squamous-cell Carcinoma Other: Blood analysis by EPISPOT and CellSearch® Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Study Start Date : September 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
CTC assay, Cetuximab
Detection & characterization of viable CTC in the peripheral blood.
Other: Blood analysis by EPISPOT and CellSearch®
Other Name: A counting of CTC using three technologies: EPISPOT, CellSearch®, flow cytometer sorter/analyzer.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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. [ Time Frame: Duration study 2 years ]
  2. Prognostic value of the CTC at baseline (EPISPOT) [ Time Frame: Duration study 2 years ]
  3. Predictive value of the early progression of CTC (EPISPOT) on the overall survival [ Time Frame: Duration study 2 years ]
  4. Compare for the first time the results with those obtained with the CellSearch® system [ Time Frame: 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 ® [ Time Frame: Duration study 2 years ]
  6. Evaluate the impact of the presence of epithelial-mesenchymal transition (EMT) marker on the prognosis [ Time Frame: Duration study 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119559


Contacts
Contact: Catherine Alix Panabieres, PhD +33467330305 c-panabieres@chu-montpellier.fr

Locations
France
Department of Otorhinolaryngology, CHU Gui de Chauliac Recruiting
Montpellier, France, 34295
Contact: Renaud GARREL, MD    +33467336920    r-garrel@chu-montpellier.fr   
Contact: Catherine PANABIERES, PhD    +33467330305    c-panabieres@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
National Cancer Institute, France
Investigators
Principal Investigator: RENAUD GARREL, MD CHU GUI DE CHAULIAC

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02119559     History of Changes
Other Study ID Numbers: 8825
ID-RCB:2011-A01174-37 ( Registry Identifier: ID-RCB )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: September 2012

Keywords provided by University Hospital, Montpellier:
Circulating Tumor Cells
Treatment Efficiency
Biomarker

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplastic Cells, Circulating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Cetuximab
Antineoplastic Agents