Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057785

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
Cancer-Related Problem/Condition Head and Neck Cancer	Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: quality-of-life assessment Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Transportability of intensity-modulated radiotherapy technique in a multi0institytuibal setting
Intensity-modulated radiotherapy treatment compliance rate

Secondary Outcome Measures:

Rate of xerostomia at 1 year (grade ≥ 2)
Rate of locoregional control at 2 years
Whole mouth saliva output relative to pretreatment measurements
Other acute and late toxicities
Chemotherapy compliance

Study Start Date:

February 2003

Detailed Description:

OBJECTIVES:

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

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*
Negative pregnancy test*
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

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
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
University of California Davis Cancer Center
Davis, California, United States, 95616
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
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
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

National Cancer Institute (NCI)

Investigators

Study Chair:

Nancy Lee, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000269314, RTOG-0225
Study First Received:	April 7, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00057785
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Pharyngeal Neoplasms
Pharyngeal Diseases
Xerostomia
Nasopharyngeal Neoplasms
Carcinoma

Epidermoid carcinoma
Nasopharyngeal carcinoma
Cisplatin
Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Stomatognathic Diseases
Carcinoma, Squamous Cell

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nasopharyngeal Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009