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CompletedNCT00057785Updated Feb 17, 2017Results posted

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

A Phase 2 interventional study of cisplatin and fluorouracil in Head and Neck Cancer, Oral Complications of Radiation Therapy and Radiation Toxicity, sponsored by Radiation Therapy Oncology Group. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Radiation Therapy Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer
  • Oral Complications of Radiation Therapy
  • Radiation Toxicity

Keywords

  • 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
03

In context

Nasopharyngeal Neoplasms

240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.

This study's enrollment of 68 is above the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.

Browse Nasopharyngeal Neoplasms studies →

Lead sponsor

Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • 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 · Drug: fluorouracil · Radiation: Intensity modulated radiation therapy

Interventions

  • Drugcisplatin

    100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127

  • Drugfluorouracil

    1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130

  • RadiationIntensity 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.

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What researchers measure

Primary outcomes

  1. Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered

    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.

    Time frame: From start of treatment to end of treatment

Secondary outcomes

  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

07

Results

Posted Oct 13, 2014

Participant flow

Participant flow — Overall Study
MilestoneIMRT +/- Chemotherapy
Started68
Completed68
Not completed0

Outcome measures

PrimaryProtocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered

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.

Time frame:
From start of treatment to end of treatment
Reported as:
Number · participants
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
participantsIMRT +/- Chemotherapy
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered9
SecondaryRate of Xerostomia at 1 Year (Grade ≥ 2)
Time frame:
From start of treatment to 1 year

Results for this outcome have not been posted.

SecondaryRate of Locoregional Control at 2 Years
Time frame:
From registration to 2 years

Results for this outcome have not been posted.

SecondaryWhole Mouth Saliva Output Relative to Pretreatment Measurements
Time frame:
From start of treatment to 1 year

Results for this outcome have not been posted.

SecondaryOther Acute and Late Toxicities
Time frame:
From start of treatment to last follow-up

Results for this outcome have not been posted.

SecondaryChemotherapy Compliance
Time frame:
From start of treatment to end of treatment

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IMRT +/- Chemotherapy—55/68 (80.9%)68/68 (100%)
Most frequent serious events
Showing 10 of 77
Most frequent serious events
EventIMRT +/- Chemotherapy
Radiation mucositisGastrointestinal disorders28/68
NauseaGastrointestinal disorders21/68
NeutropeniaInvestigations20/68
Vomiting NOSGastrointestinal disorders19/68
DysphagiaGastrointestinal disorders16/68
Esophagitis NOSGastrointestinal disorders13/68
Weight decreasedInvestigations12/68
HyponatremiaMetabolism and nutrition disorders12/68
LymphopeniaInvestigations11/68
DehydrationMetabolism and nutrition disorders11/68
Most frequent other events
Showing 10 of 81
Most frequent other events
EventIMRT +/- Chemotherapy
Dry mouthGastrointestinal disorders61/68
Salivary gland disorder NOSGastrointestinal disorders59/68
Hemoglobin decreasedBlood and lymphatic system disorders51/68
Late RT toxicity: Salivary gland: NOSGastrointestinal disorders51/68
Radiation mucositisGastrointestinal disorders50/68
FatigueGeneral disorders50/68
Leukopenia NOSInvestigations50/68
NauseaGastrointestinal disorders46/68
Dermatitis radiation NOSInjury, poisoning and procedural complications43/68
Late RT toxicity: Mucous membrane: NOSGastrointestinal disorders41/68

Baseline characteristics

All eligible patients

Age, Continuous
Age, Continuous(years)IMRT +/- Chemotherapy
Median48.5 (18 to 73)
Gender
Gender(Participants)IMRT +/- Chemotherapy
Female17
Male51
08

Study locations

17 sites
  • Comprehensive Cancer Center at University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • University of California Davis Cancer Center
    Davis, California 95616, United States
  • Radiological Associates of Sacramento Medical Group, Incorporated
    Sacramento, California 95815, United States
  • UCSF Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital
    St Louis, Missouri 63110, United States
  • Monmouth Medical Center
    Long Branch, New Jersey 07740, United States
  • Albuquerque Regional Medical Center at Lovelace Sandia Health System
    Albuquerque, New Mexico 87102, United States
  • Akron City Hospital
    Akron, Ohio 44304, United States
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    Philadelphia, Pennsylvania 19107, United States
  • Fox Chase-Temple Cancer Center
    Philadelphia, Pennsylvania 19111-2497, United States
  • CCOP - MainLine Health
    Wynnewood, Pennsylvania 19096, United States
  • M.D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030, United States
  • Wilford Hall Medical Center
    Lackland AFB, Texas 78236, United States
  • McKay-Dee Hospital Center
    Ogden, Utah 84403, United States
  • Medical College of Wisconsin Cancer Center
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Publications

  • 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. PubMed 20441239 ↗
  • 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. PubMed 19564532 ↗
  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00057785
Lead sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 9, 2003
Start date
Feb 2003
Primary completion
Feb 2007
Completion
Dec 2016
Results posted
Oct 13, 2014
Last update
Feb 17, 2017

Study contacts

Nancy Lee, MD
study chair · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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