Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
This study has been completed.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057785
First received: April 7, 2003
Last updated: August 12, 2010
Last verified: November 2005
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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 Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase 2 |
| Study Type: | Observational |
| 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 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 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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 | |
| 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:
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.
| ClinicalTrials.gov Identifier: | NCT00057785 History of Changes |
| Other Study ID Numbers: | CDR0000269314, RTOG-0225 |
| Study First Received: | April 7, 2003 |
| Last Updated: | August 12, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Nasopharyngeal Neoplasms Radiation Injuries Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Wounds and Injuries |
Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013