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.
Head and Neck Cancer
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma|
- Survival Rate of Patients [ Time Frame: up to 77 months ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2002|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: High-Dose Radiation Therapy Plus Chemotherapy
|Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Radiation: radiation therapy|
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052429
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Suzanne Wolden, MD||Memorial Sloan Kettering Cancer Center|