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NCT Number: NCT00052429

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan - Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

Fluorouracil

Drug

adjuvant therapy

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Survival Rate of Patients

    Time frame: up to 77 months

    Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.

  2. Local Control of Participants

    Time frame: every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.

    Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2003
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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