Head and Neck Cancer Clinical Trial
Official title:
Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
Verified date | December 2017 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan - Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
United States,
Bakst RL, Lee N, Pfister DG, Zelefsky MJ, Hunt MA, Kraus DH, Wolden SL. Hypofractionated dose-painting intensity modulated radiation therapy with chemotherapy for nasopharyngeal carcinoma: a prospective trial. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival Rate of Patients | 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. | up to 77 months | |
Primary | Local Control of Participants | 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. | 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. |
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