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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
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 |
|---|---|---|
|
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 II |
| Study Type: | Observational |
| Official Title: | A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer |
| Study Start Date: | February 2003 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and 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 | |
| Study Chair: | Nancy Lee, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000269314, RTOG-0225 |
| Study First Received: | April 7, 2003 |
| Last Updated: | July 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00057785 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Antimetabolites, Antineoplastic Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pharyngeal Neoplasms Immunosuppressive Agents Pharyngeal Diseases |
Pharmacologic Actions Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Fluorouracil Nasopharyngeal Diseases Stomatognathic Diseases |
