Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 70	Pharmaceutical / Industry	EORTC-24971 RP-56976-V-323, NCT00003888

Objectives

I.  Compare the progression free survival of patients with locally advanced, 
inoperable squamous cell carcinoma of the head and neck treated with cisplatin 
plus fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy.

II.  Compare the response rate, response duration, toxicity, local symptoms, 
and time to disease progression of these treatment regimens in this patient 
population.

III.  Evaluate the quality of life in these patients.

Entry Criteria

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

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

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

Expected Enrollment

A total of 348 patients will be accrued for this study within 24 months.

Outline

This is a randomized, multicenter study. Patients are stratified according to 
primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and 
institution. Patients are randomized to one of two treatment arms.

Arm I: Patients receive docetaxel IV over 1 hour, immediately followed by 
cisplatin IV over 1 hour on day 1 and fluorouracil (5-FU) IV as a continuous 
infusion on days 1-5.  

Arm II: Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV 
as a continuous infusion on days 1-5. 

Treatment continues every 3 weeks for 4 courses in the absence of disease 
progression or unacceptable toxicity.

Patients receive radiotherapy following chemotherapy within 3-6 weeks of last 
course. Radiotherapy is administered 5 days a week for up to 7 weeks.

Quality of life is assessed before treatment, at courses 2 and 4, and at 6 and 
9 months.

Patients are followed every 3 months for the first 2 years and then every 6 
months until death.

Vermorken JB, Remenar E, van Herpen C, et al.: Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med 357 (17): 1695-704, 2007.[PUBMED Abstract]

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 (SCCHN): EORTC study 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5522, 285s, 2006.

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 and neck (SCCHN). Final analysis of EORTC 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5516, 2006.

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 III trial of the EORTC Head and Neck Cancer Group (EORTC #24971). [Abstract] J Clin Oncol 22 (Suppl 14): A-5508, 490s, 2004.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jan Vermorken, MD, PhD, Protocol chair		Ph: 32-03-821-3954 Email: Jan.B.Vermorken@uza.be

Registry Information
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
Trial Start Date		1999-04-13
Registered in ClinicalTrials.gov		NCT00003888
Date Submitted to PDQ		1999-05-04
Information Last Verified		2007-10-26

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