Head and Neck Cancer Clinical Trial
Official title:
A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Verified date | July 2015 |
Source | European Organisation for Research and Treatment of Cancer - EORTC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
Combining more than one drug and combining chemotherapy with radiation therapy may kill more
tumor cells. It is not yet known which regimen of combination chemotherapy is more effective
for advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
combination chemotherapy plus radiation therapy in treating patients who have advanced head
and neck cancer.
Status | Completed |
Enrollment | 359 |
Est. completion date | March 2015 |
Est. primary completion date | March 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced squamous
cell carcinoma of the head and neck Stage III or IV without distant metastases Unresectable
Primary tumor sites: Oral cavity Oropharynx Hypopharynx Larynx Must have at least one
measurable lesion PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 5 times ULN No SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since prior myocardial infarction No unstable, treated cardiac disease Pulmonary: At least one year since prior hospitalization for chronic obstructive pulmonary disease Neurologic: No neurologic or psychiatric disorders (e.g., dementia or seizures) No concurrent peripheral neuropathy greater than grade 1 Other: No active uncontrolled infection No active peptic ulcer No alteration in hearing At least 5 years since any other neoplastic disease except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated by surgery Not pregnant or nursing Fertile patients must use effective contraception No other psychological, familial, sociological, or geographical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No primary prophylactic colony stimulating factors during the first course of therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior corticosteroid No chronic corticosteroid therapy (greater than 3 months) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for this cancer Other: At least 30 days since prior treatment in a clinical trial No concurrent use of drugs that interact with fluorouracil (e.g., cimetidine, allopurinol, folic acid or leucovorin calcium) No other concurrent investigational drugs or anticancer treatment |
Country | Name | City | State |
---|---|---|---|
Austria | Landeskrankenhaus/Universitatskliniken Graz | Graz | |
Austria | Allgemeines Krankenhaus der Stadt Wien | Vienna | |
Austria | Kaiser Franz Josef Hospital | Vienna | |
Belgium | Algemeen Ziekenhuis Middelheim | Antwerp | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | Centre Hospitalier Regional de la Citadelle | Liege | |
Belgium | Clinique Universitaire De Mont-Godinne | Mont-Godinne Yvoir | |
Former Yugoslavia | Institute of Oncology and Radiology of Serbia | Belgrade | |
France | CHR de Besancon - Hopital Jean Minjoz | Besancon | |
France | Centre Oscar Lambret | Lille | |
France | Centre Hospital Regional Universitaire de Limoges | Limoges | |
France | Centre Leon Berard | Lyon | |
France | CHR Hotel Dieu | Nantes | |
France | CRLCC Nantes - Atlantique | Nantes-Saint Herblain | |
France | Centre Antoine Lacassagne | Nice | |
Germany | Martin Luther Universitaet | Halle | |
Germany | Caritasklinik St. Theresia | Saarbrucken | |
Germany | Mutterhaus der Borromaerinnen | Trier | |
Greece | Ahepa University Hospital | Thessaloniki | |
Hungary | National Institute of Oncology | Budapest | |
Hungary | Szent Margit Hospital | Budapest | |
Hungary | Borsod-Abauj-Zemplen County Hospital | Miskolc | |
Italy | Centro di Riferimento Oncologico - Aviano | Aviano | |
Italy | Ospedale Santa Croce | Cuneo | |
Italy | Istituti Fisioterapici Ospitalieri - Roma | Rome | |
Italy | Ospedale di Circolo e Fondazione Macchi | Varese | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
Netherlands | University Medical Center Nijmegen | Nijmegen | |
Poland | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | |
Slovakia | National Cancer Institute - Bratislava | Bratislava | |
Spain | Institut Catala d'Oncologia - Hospital Duran i Reynals | Barcelona | |
Spain | Hospital General de Jerez | Jerez | |
Spain | Universidad de Santiago - Hospital de Conxo | Santiago de Compostela | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Switzerland | Kantonspital Aarau | Aarau | |
Switzerland | Ospedale San Giovanni | Bellinzona | |
Turkey | Istanbul University-Institute of Oncology | Istanbul | |
United Kingdom | Beatson Oncology Centre | Glasgow | Scotland |
United Kingdom | Charing Cross Hospital | London | England |
United Kingdom | Middlesex Hospital- Meyerstein Institute | London | England |
United Kingdom | Newcastle General Hospital | Newcastle Upon Tyne | England |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Austria, Belgium, Former Yugoslavia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Switzerland, Turkey, United Kingdom,
Bernier J, Coens C, Remenar E, et al.: Impact on quality of life (QoL) of the addition of docetaxel (T) to neoadjuvant cisplatin plus 5-fluorouracil treatment in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCC
Jansen J, Vermorken JB, Boote D, et al.: Cost-effectiveness analysis of the EORTC 24971 (TAX 323) trial comparing docetaxel plus cisplatin and 5-fluorouracil versus standard treatment (cisplatin and 5-fluorouracil) as induction chemotherapy followed by radiation therapy in locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 25 (Suppl 18): A-6090, 321s, 2007.
Remenar E, Van Herpen C, Lluch JG, et al.: A randomized phase III multicenter trial of neoadjuvant docetaxel plus cisplatin and 5-fluorouracil (TPF) versus neoadjuvant PF in patients with locally advanced unresectable squamous cell carcinoma of the head a
van Herpen CM, Mauer ME, Mesia R, Degardin M, Jelic S, Coens C, Betka J, Bernier J, Remenar E, Stewart JS, Preiss JH, van den Weyngaert D, Bottomley A, Vermorken JB; EORTC Head and Neck Group. Short-term health-related quality of life and symptom control — View Citation
Vermorken JB, Remenar E, Van Herpen C, et al.: Standard cisplatin/infusional 5-fluorouracil (PF) vs docetaxel (T) plus PF (TPF) as neoadjuvant chemotherapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN): a phase
Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fl — View Citation
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