Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.

Further Study Information

OBJECTIVES:

• Determine the feasibility of dose-painting using accelerated fractionation intensity modulated radiotherapy with chemotherapy in patients with stage II-IVB nasopharyngeal cancer.

• Determine the toxicity, including xerostomia and ototoxicity, of this regimen in these patients.

• Determine the rates of local-regional control and survival of patients treated with this regimen.

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.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed nasopharyngeal cancer

• Stage II-IVB

• Newly diagnosed

• No distant metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• 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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Suzanne Wolden

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00052429
Information obtained from ClinicalTrials.gov on February 06, 2012

Back to Top