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A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma


Phase 3
18 Years
75 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma


OBJECTIVES:

- Compare the efficacy of radiotherapy (in terms of local-regional control) with or
without epoetin alfa in patients with squamous cell carcinoma of the head and neck.

- Compare the disease-specific and overall survival of patients treated with these
regimens.

- Compare the hemoglobin level of these patients during radiotherapy.

- Compare the acute and late toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, site of disease (larynx vs hypopharynx vs
oropharynx vs oral cavity), T-classification (T1-2 vs T3-4), N-classification and intent of
systematic neck node dissection (N0-1 vs N2-3 without node dissection vs N2-3 with node
dissection), hemoglobin level and gender (men with 10-12.5 g/dL vs men with 12.5-14 g/dL vs
women with 10-12 g/dL vs women with 12-13.5 g/dL), and type of treatment (EORTC standard vs
other vs randomized in other trials). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard radiotherapy 5 days a week and receive concurrent
epoetin alfa subcutaneously (SC) once weekly.

- Arm II: Patients undergo radiotherapy as in arm I and receive concurrent placebo SC
once weekly.

Treatment on both arms continues for 6-8 weeks in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 3-6 weeks and 9-14 weeks, every 3 months for 2 years, every 6
months for 1 year, and then annually thereafter. After any locoregional recurrence, patients
are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oral cavity, larynx,
oropharynx, or hypopharynx

- Stage T1-T4, any N

- No T1, N0 glottic tumor

- No nodal disease from unknown primary

- Previously untreated disease

- No distant metastases

- Planned radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin greater than 10 g/dL but no greater than 14 g/dL for men

- Hemoglobin greater than 10 g/dL but no greater than 13.5 g/dL for women

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No hypertension (diastolic pressure greater than 100 mmHg) refractory to treatment

- No symptomatic cardiovascular disease

- No deep vein thrombosis

Other:

- No other malignancy except cured basal cell skin cancer or carcinoma in situ of the
cervix

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- No smoking during study

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior neoadjuvant chemotherapy

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to head and neck area

- No concurrent nonconventional radiotherapy

Surgery:

- No prior therapeutic surgery to head and neck area

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Philippe Lambin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Maastricht University Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-22996-24002

NCT ID:

NCT00017277

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage I squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • 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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