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NCT00057785 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-02-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered

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outcome · NOT POSTED

Rate of Xerostomia at 1 Year (Grade ≥ 2)

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outcome · NOT POSTED

Rate of Locoregional Control at 2 Years

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outcome · NOT POSTED

Whole Mouth Saliva Output Relative to Pretreatment Measurements

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outcome · NOT POSTED

Other Acute and Late Toxicities

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outcome · NOT POSTED

Chemotherapy Compliance

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
    intervention Names
    1. Drug: cisplatin
    2. Drug: fluorouracil
    3. Radiation: Intensity modulated radiation therapy
    label
    IMRT +/- chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. IMRT +/- chemotherapy
    description
    100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. IMRT +/- chemotherapy
    description
    1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
    name
    fluorouracil
    type
    DRUG
  3. arm Group Labels
    1. IMRT +/- chemotherapy
    description
    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.
    name
    Intensity modulated radiation therapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
68
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
    time Frame
    From start of treatment to end of treatment
secondary Outcomes
  1. measure
    Rate of Xerostomia at 1 Year (Grade ≥ 2)
    time Frame
    From start of treatment to 1 year
  2. measure
    Rate of Locoregional Control at 2 Years
    time Frame
    From registration to 2 years
  3. measure
    Whole Mouth Saliva Output Relative to Pretreatment Measurements
    time Frame
    From start of treatment to 1 year
  4. measure
    Other Acute and Late Toxicities
    time Frame
    From start of treatment to last follow-up
  5. measure
    Chemotherapy Compliance
    time Frame
    From start of treatment to end of treatment
Full study description
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.
detailed Description
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.
Source references
references
  1. citation
    Chen A, Lee N, Yang C, Liu T, Narayan S, Vijayakumar S, Purdy J. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8. doi: 10.1177/153303461000900308.
    pmid
    20441239
    type
    RESULT
  2. citation
    Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.
    pmid
    19564532
    type
    RESULT
  3. citation
    Lee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      1. context exact
        More late complications were reported among patients in the 2DRT group.</li></ul></div></li><li>The phase II <a href="https://clinicaltrials.gov/ct2/show/study/NCT00057785" title="https://clinicaltrials.gov/ct2/show/study/NCT00057785">RTOG-0225</a> study tested the feasibility of IMRT in a multi-institutional setting.[<a href="#c
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      2. context exact
        RT group.</li></ul></div></li><li>The phase II <a href="https://clinicaltrials.gov/ct2/show/study/NCT00057785" title="https://clinicaltrials.gov/ct2/show/study/NCT00057785">RTOG-0225</a> study tested the feasibility of IMRT in a multi-institutional setting.[<a href="#cit/section_1.33">33</a>]<div class="pdq-content-list"><ul id="
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice