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Trial record 17 of 62 for:    dry mouth | NIH

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00057785
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : October 13, 2014
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

April 7, 2003
April 9, 2003
October 8, 2014
October 13, 2014
February 17, 2017
February 2003
February 2007   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00057785 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Oral Complications of Radiation Therapy
  • Radiation Toxicity
  • Drug: cisplatin
    100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
  • Drug: fluorouracil
    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.
Experimental: IMRT +/- chemotherapy
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Interventions:
  • Drug: cisplatin
  • Drug: fluorouracil
  • Radiation: Intensity modulated radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
Not Provided
December 2016
February 2007   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx

    • WHO I-III
    • No stage IVC disease
    • No evidence of distant metastasis
  • Measurable or evaluable disease
  • Must have been treated with primary radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • White blood cell count (WBC) at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine no greater than 1.6 mg/dL
  • Creatinine clearance at least 60 mL/min

Other

  • Not pregnant (If stage T2b or greater or node-positive disease)
  • Negative pregnancy test (If stage T2b or greater or node-positive disease)
  • No other prior head and neck cancer
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No active untreated infection
  • No other major medical or psychiatric illness that would preclude study entry
  • Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 6 months since prior radiotherapy for head and neck cancer

Surgery

  • No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies

Other

  • No other concurrent experimental therapy for cancer
  • No amifostine or pilocarpine during or for 3 months after radiotherapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00057785
RTOG-0225
CDR0000269314
Yes
Not Provided
Not Provided
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
Radiation Therapy Oncology Group
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP