Informations générales (source: ClinicalTrials.gov)
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. (CIRCUTEC)
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
septembre 2012
mars 2018
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Joel GUIGAY | 15/04/2024 14:28:33 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Department of Otorhinolaryngology, CHU Gui de Chauliac - 34295 - Montpellier - France | Renaud GARREL, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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