High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 1/11/2018 |
| Start Date: | September 2002 |
| End Date: | November 2010 |
Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
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.
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.
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.
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.
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
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