Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00057785|
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : October 13, 2014
Last Update Posted : February 17, 2017
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oral Complications of Radiation Therapy Radiation Toxicity||Drug: cisplatin Drug: fluorouracil Radiation: Intensity modulated radiation therapy||Phase 2|
- Determine the transportability of IMRT to a multi-institutional setting.
- Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
- Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
- Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
- Determine the acute and late toxicity of these regimens in these patients.
- Determine chemotherapy compliance in patients treated with these regimens.
OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity.
Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.
Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||December 2016|
Experimental: IMRT +/- chemotherapy
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
Radiation: Intensity modulated radiation therapy
The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.
- Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered [ Time Frame: From start of treatment to end of treatment ]Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.
- Rate of Xerostomia at 1 Year (Grade ≥ 2) [ Time Frame: From start of treatment to 1 year ]
- Rate of Locoregional Control at 2 Years [ Time Frame: From registration to 2 years ]
- Whole Mouth Saliva Output Relative to Pretreatment Measurements [ Time Frame: From start of treatment to 1 year ]
- Other Acute and Late Toxicities [ Time Frame: From start of treatment to last follow-up ]
- Chemotherapy Compliance [ Time Frame: From start of treatment to end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057785
|Study Chair:||Nancy Lee, MD||Memorial Sloan Kettering Cancer Center|