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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00057785
First received: April 7, 2003
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity
Drug: cisplatin
Drug: fluorouracil
Radiation: Intensity modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered [ Time Frame: From start of treatment to end of treatment ] [ Designated as safety issue: No ]
    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:
  • Rate of Xerostomia at 1 Year (Grade ≥ 2) [ Time Frame: From start of treatment to 1 year ] [ Designated as safety issue: Yes ]
  • Rate of Locoregional Control at 2 Years [ Time Frame: From registration to 2 years ] [ Designated as safety issue: No ]
  • Whole Mouth Saliva Output Relative to Pretreatment Measurements [ Time Frame: From start of treatment to 1 year ] [ Designated as safety issue: No ]
  • Other Acute and Late Toxicities [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
  • Chemotherapy Compliance [ Time Frame: From start of treatment to end of treatment ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057785

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

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057785     History of Changes
Other Study ID Numbers: RTOG-0225, CDR0000269314
Study First Received: April 7, 2003
Results First Received: October 8, 2014
Last Updated: October 8, 2014
Health Authority: United States: Federal Government

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:
Head and Neck Neoplasms
Radiation Injuries
Neoplasms
Neoplasms by Site
Wounds and Injuries
Cisplatin
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014