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

Brief Summary:

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IMRT +/- chemotherapy
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Rate of Xerostomia at 1 Year (Grade ≥ 2) [ Time Frame: From start of treatment to 1 year ]
  2. Rate of Locoregional Control at 2 Years [ Time Frame: From registration to 2 years ]
  3. Whole Mouth Saliva Output Relative to Pretreatment Measurements [ Time Frame: From start of treatment to 1 year ]
  4. Other Acute and Late Toxicities [ Time Frame: From start of treatment to last follow-up ]
  5. Chemotherapy Compliance [ Time Frame: From start of treatment to end of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


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


  • Not specified


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


  • 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


Biologic therapy

  • Not specified


  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Not specified


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


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


  • No other concurrent experimental therapy for cancer
  • No amifostine or pilocarpine during or for 3 months after radiotherapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00057785

Show Show 17 study locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
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Study Chair: Nancy Lee, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
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Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00057785    
Other Study ID Numbers: RTOG-0225
First Posted: April 9, 2003    Key Record Dates
Results First Posted: October 13, 2014
Last Update Posted: February 17, 2017
Last Verified: December 2016
Keywords provided by Radiation Therapy Oncology Group:
oral complications of radiation therapy
radiation toxicity
stage I squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs