Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of fractionation intensity modulated radiotherapy with dose painting plus chemotherapy
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Suzanne Wolden, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
02-077
NCT ID:
NCT00052429
Start Date:
September 2002
Completion Date:
November 2010
Related Keywords:
- Head and Neck Cancer
- stage II lymphoepithelioma of the nasopharynx
- stage II squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Memorial Sloan - Kettering Cancer Center | New York, New York 10021 |
