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A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006) |
|
| ARM B | Active Comparator | RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel - cisplatin - 5-fluorouracil | Drug | docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and late toxicities in the two arms | 5 years | |
| Progression free survival | 5 years | |
| Locoregional control |
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Inclusion Criteria:
Specific procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARCO MERLANO, MD | ASCO, ESMO, AIOM, G.O.N.O. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale S. Giacomo | Novi Ligure (al) | Italy | Italy | |||
| Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | - J.P. Pignon et al. Lancet 2000 | ||
| Result | - A. Forastiere et al., New Engl J Med 2001 | ||
| Result | - Adelstein DJ J.Clin.Oncol. 2003 | ||
| Result | - Henke, New England 2004 | ||
| Result | - J.A. Bonner et al., New Engl J Med 2006 | ||
| 16476835 | Result |
| Label | URL |
|---|---|
| click on "trials" for more informations | View source |
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| radiotherapy | Radiation | Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated. |
|
| cetuximab | Drug | 400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment |
|
| cisplatin | Drug | Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment. |
|
| radiotherapy | Radiation | Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated. |
|
| 5 years |
| Response rate | 5 years |
| Rionero in Vulture (pz) |
| Italy |
| Italy |
| Ospedale Civile Ss. Antonio E Biagio | Alessandria | Italy |
| Ausl Della Valle D' Aosta | Aosta | Italy |
| Policlinico S. Orsola-Malpighi | Bologna | Italy |
| Asl 8 - Ospedale Businco | Cagliari | Italy |
| A.S.O. S. Croce E Carle | Cuneo | 12100 | Italy |
| Irccs - Aou S. Martino - Oncology | Genoa | Italy |
| Irccs - Aou San Martino - Radiotherapy | Genoa | Italy |
| Asl 3 Genovese | Genova | Italy |
| E.O. Ospedali Galliera | Genova | Italy |
| Azienda Ospedaliera Villa Scassi - Asl3 | Italy | Italy |
| Istituto Nazionale Dei Tumori | Milan | Italy |
| Azienda Ospedaliero Universitaria Di Modena | Modena | Italy |
| Azienda Ospedaliero-Universitaria Di Parma | Parma | Italy |
| Azienda Ospedaliera Ospedali Riuniti Di Fano | Pesaro | Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | Italy |
| Ospedale S. Filippo Neri | Roma | Italy |
| Ospedale S. Paolo | Savona | Italy |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to) | Turin | Italy |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino | Turin | Italy |
| Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146. |
| Result | - Posner M et al, New Engl J Med 2007 |
| Result | - Vermorken J et al, New Engl J Med 2007 |
| Result | - Lo Nigro, Journal of Cancer Research Clinical Oncology 2009 |
| 12927569 | Result | Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7. |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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