Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00052429


Primary Contact:

Study Chair
Suzanne Wolden, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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