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
18 Years
70 Years
Both
Head and Neck Cancer
Trial Information
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
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.
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.
PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Jan B. Vermorken, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Ziekenhuis Antwerpen
Authority:
United States: Federal Government
Study ID:
EORTC-24971
NCT ID:
NCT00003888
Start Date:
April 1999
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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