Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
- Determine the feasibility of dose-painting using accelerated fractionation intensity
modulated radiotherapy with chemotherapy in patients with stage II-IVB nasopharyngeal
- Determine the toxicity, including xerostomia and ototoxicity, of this regimen in these
- Determine the rates of local-regional control and survival of patients treated with
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting
- 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
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of fractionation intensity modulated radiotherapy with dose painting plus chemotherapy
Suzanne Wolden, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan - Kettering Cancer Center||New York, New York 10021|