Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI MSKCC-02077 NCI-H02-0101, NCT00052429

Objectives

1. Determine the feasibility of dose-painting using accelerated fractionation intensity modulated radiotherapy with chemotherapy in patients with stage II-IVB nasopharyngeal cancer.
2. Determine the toxicity, including xerostomia and ototoxicity, of this regimen in these patients.
3. Determine the rates of local-regional control and survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed nasopharyngeal cancer
  • Stage II-IVB
  • Newly diagnosed



• No distant metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for this diagnosis
• More than 3 years since other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for this diagnosis
• More than 3 years since other prior radiotherapy
• No prior radiotherapy to the head and neck region

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN
• AST no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Calcium no greater than 11.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
• No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

Expected Enrollment

Approximately 10-74 patients (10-20 for phase I and 54 for phase II) will be accrued for this study.

Outcomes

Feasibility of fractionation intensity modulated radiotherapy with dose painting plus chemotherapy
Toxicity
Rates of local-regional control and survival

Outline

Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.

Phase I

• Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.



• Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.



• Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

  In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.

Phase II

• Patients are treated as in phase I.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Suzanne Wolden, MD, Protocol chair		Ph: 212-639-5148; 800-525-2225 Email: woldens@mskcc.org

Registry Information
Official Title		Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients with Stage II-IVB Nasopharyngeal Carcinoma
Trial Start Date		2002-09-10
Trial Completion Date		2007-11-30
Registered in ClinicalTrials.gov		NCT00052429
Date Submitted to PDQ		2002-10-01
Information Last Verified		2008-10-22
NCI Grant/Contract Number		CA59017, CA08748

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