Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care, Treatment | Active | 18 and over | NCI, Other | CDR0000675520 NCCTG-N09C6, N09C6, NCT01156142 |
Summary
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.
Further Study Information
OBJECTIVES:
Primary
- Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective in reducing oral mucositis-related pain in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy.
Secondary
- Assess the adverse event profile of these regimens, using a patient-reported questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
- Compare the incidence of using alternative analgesics 4 hours before and in between these regimens in these patients.
- Assess patient preference for continuing therapy with oral doxepin hydrochloride after initial test rinse or after optional cross-over phase.
Tertiary
- Assess pain reduction and other adverse event profile in patients who cross-over to the optional blinded phase using the same patient-reported questionnaire.
- Assess pain reduction and other adverse event profile in patients who continue to receive optional oral doxepin hydrochloride.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm I on day 2.
NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes before and after study medication.
After completing study therapy, patients have the option to receive doxepin hydrochloride oral rinse every 4 hours as needed during radiotherapy.
Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes after study medication. Patients who choose to continue doxepin hydrochloride oral rinse also complete weekly questionnaires.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed head and neck cancer meeting the following criteria:
- Undergoing radiotherapy with or without chemotherapy
- At least 1/3 of the oral cavity mucosa must be included in the radiotherapy field
- Oral pain related to mucositis of ≥ grade 4 and for which the patient wants relief as measured by patient response to a pain scale question rating (0 to 10)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No known allergy to doxepin hydrochloride, tricyclic antidepressants, or any known component of the drug formulation
- No untreated or unresolved oral candidiasis or oral herpes simplex virus infection
- No untreated narrow-angle glaucoma
- No untreated urinary retention in the past 6 weeks
- No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study, or interfere significantly with proper assessment of safety and toxicity of the prescribed regimens
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior tricyclic antidepressant or monoamine oxidase inhibitor
- No viscous lidocaine, 'magic mouthwash', benzocaine, diphenhydramine, or other medicated oral rinse within 4 hours before or after the study medication
- Normal saline or baking soda rinse allowed
Trial Lead Organizations/Sponsors
North Central Cancer Treatment Group
National Cancer Institute| Robert C. Miller |  | Study Chair |
Trial Sites
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| U.S.A. | |||
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| Arizona | |||
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| Scottsdale | |||
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| Mayo Clinic Scottsdale | |||
| Robert C. Miller | Ph: 507-538-7623 | ||
| Connecticut | |||
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| Hartford | |||
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| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Florida | |||
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| Jacksonville | |||
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| Mayo Clinic - Jacksonville | |||
| Robert C. Miller | Ph: 507-538-7623 | ||
| Hawaii | |||
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| Aiea | |||
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| Kapiolani Medical Center at Pali Momi | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Honolulu | |||
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| Cancer Research Center of Hawaii | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Hawaii Medical Center - East | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Kapiolani Medical Center for Women and Children | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| OnCare Hawaii, Incorporated - Kuakini | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| OnCare Hawaii, Incorporated - Lusitana | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Queen's Cancer Institute at Queen's Medical Center | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Straub Clinic and Hospital, Incorporated | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Tripler Army Medical Center | |||
| Jeffrey L. Berenberg | Ph: 808-586-2979 | ||
| Kailua | |||
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| Castle Medical Center | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Lihue | |||
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| Kauai Medical Clinic | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Wailuku | |||
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| Maui Memorial Medical Center | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Pacific Cancer Institute - Maui | |||
| William S. Loui | Ph: 808-586-2979 | ||
| Email: dorothy@crch.hawaii.edu | |||
| Idaho | |||
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| Boise | |||
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| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Illinois | |||
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| Moline | |||
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| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Indiana | |||
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| Beech Grove | |||
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| St. Francis Hospital and Health Centers - Beech Grove Campus | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Elkhart | |||
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| Elkhart Clinic, LLC | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Elkhart General Hospital | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Michiana Hematology-Oncology, PC - Elkhart | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Kokomo | |||
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| Community Cancer Care at Howard Regional Health System | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| La Porte | |||
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| Center for Cancer Therapy at LaPorte Hospital and Health Services | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Mishawaka | |||
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| Michiana Hematology-Oncology, PC - Mishawaka | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Saint Joseph's Medical Center | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Plymouth | |||
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| Michiana Hematology Oncology PC - Plymouth | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Richmond | |||
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| Reid Hospital & Health Care Services | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| South Bend | |||
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| CCOP - Northern Indiana CR Consortium | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Memorial Hospital of South Bend | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Michiana Hematology-Oncology, PC - South Bend | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Westville | |||
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| Michiana Hematology Oncology-PC Westville | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Iowa | |||
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| Mason City | |||
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| Mercy Cancer Center at Mercy Medical Center - North Iowa | |||
| Arvind Y Vemula | Ph: 800-433-3883 | ||
| Ottumwa | |||
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| South Iowa Radiation Oncology Center at Ottumwa Regional Health Center | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| Massachusetts | |||
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| Boston | |||
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| Boston University Cancer Research Center | |||
| Minh T Truong | Ph: 617-638-8265 | ||
| Michigan | |||
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| Ann Arbor | |||
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| CCOP - Michigan Cancer Research Consortium | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Saint Joseph Mercy Cancer Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Battle Creek | |||
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| Battle Creek Health System Cancer Care Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Big Rapids | |||
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| Mecosta County Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Dearborn | |||
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| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Detroit | |||
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| Van Elslander Cancer Center at St. John Hospital and Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Flint | |||
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| Genesys Hurley Cancer Institute | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Hurley Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Grand Blanc | |||
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| Genesys Regional Medical Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Grand Rapids | |||
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| Butterworth Hospital at Spectrum Health | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| CCOP - Grand Rapids | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Lacks Cancer Center at Saint Mary's Health Care | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Jackson | |||
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| Gayle M. Jacob Cancer Center at Allegiance Health | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Lansing | |||
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| Sparrow Regional Cancer Center | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Livonia | |||
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| St. Mary Mercy Hospital | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Muskegon | |||
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| Mercy General Health Partners | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Pontiac | |||
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| St. Joseph Mercy Oakland | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Port Huron | |||
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| Mercy Regional Cancer Center at Mercy Hospital | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Saginaw | |||
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| Seton Cancer Institute at Saint Mary's - Saginaw | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Saint Joseph | |||
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| Lakeside Cancer Specialists, PLLC | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| St. Joseph | |||
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| Lakeland Regional Cancer Care Center - St. Joseph | |||
| Michael W. Method | Ph: 574-237-1328 | ||
| Traverse City | |||
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| Munson Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Warren | |||
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| St. John Macomb Hospital | |||
| Philip J. Stella | Ph: 734-712-3456 | ||
| Minnesota | |||
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| Alexandria | |||
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| Medini, Eitan MD (UIA Investigator) | |||
| Donald J Jurgens | Ph: 877-229-4907 | ||
| Email: coborncancercenter@centracare.com | |||
| Bemidji | |||
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| MeritCare Bemidji | |||
| Preston D. Steen | Ph: 701-234-6161 | ||
| Burnsville | |||
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| Fairview Ridges Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Coon Rapids | |||
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| Mercy and Unity Cancer Center at Mercy Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Edina | |||
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| Fairview Southdale Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Fridley | |||
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| Mercy and Unity Cancer Center at Unity Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Hutchinson | |||
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| Hutchinson Area Health Care | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Mankato | |||
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| Immanuel St. Joseph's | |||
| Mohmmad J Ranginwala | Ph: 507-385-2929 | ||
| Maplewood | |||
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| HealthEast Cancer Care at St. John's Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Minnesota Oncology - Maplewood | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Minneapolis | |||
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| Hennepin County Medical Center - Minneapolis | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| New Ulm | |||
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| New Ulm Medical Center | |||
| Patrick J. Flynn | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Robbinsdale | |||
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| Humphrey Cancer Center at North Memorial Outpatient Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Rochester | |||
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| Mayo Clinic Cancer Center | |||
| Robert C. Miller | Ph: 507-538-7623 | ||
| North Central Cancer Treatment Group | |||
| Robert C. Miller | Ph: 507-284-4827 | ||
| Email: miller.robert2@mayo.edu | |||
| Saint Cloud | |||
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| CentraCare Clinic - Women and Children | |||
| Donald J Jurgens | Ph: 877-229-4907 | ||
| Email: coborncancercenter@centracare.com | |||
| Coborn Cancer Center | |||
| Donald J Jurgens | Ph: 877-229-4907 | ||
| Email: coborncancercenter@centracare.com | |||
| Saint Louis Park | |||
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| CCOP - Metro-Minnesota | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Park Nicollet Cancer Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Saint Paul | |||
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| Regions Hospital Cancer Care Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| United Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Shakopee | |||
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| St. Francis Cancer Center at St. Francis Medical Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Stillwater | |||
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| Lakeview Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Waconia | |||
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| Ridgeview Medical Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Willmar | |||
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| Willmar Cancer Center at Rice Memorial Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Woodbury | |||
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| Minnesota Oncology - Woodbury | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Missouri | |||
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| Bolivar | |||
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| Central Care Cancer Center at Carrie J. Babb Cancer Center | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Joplin | |||
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| St. John's Regional Medical Center | |||
| Mark Joseph Skelley | Ph: 417-625-2488 | ||
| Springfield | |||
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| Cancer Research for the Ozarks | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Hulston Cancer Center at Cox Medical Center South | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| St. John's Regional Health Center | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Nebraska | |||
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| Lincoln | |||
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| Cancer Resource Center - Lincoln | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| Omaha | |||
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| Alegant Health Cancer Center at Bergan Mercy Medical Center | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| CCOP - Missouri Valley Cancer Consortium | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| Creighton University Medical Center | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| Immanuel Medical Center | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| Lakeside Hospital | |||
| Gamini S. Soori | Ph: 800-253-4368 | ||
| New Mexico | |||
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| Albuquerque | |||
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| University of New Mexico Cancer Center | |||
| Julie E Bauman | Ph: 505-727-8000 | ||
| North Carolina | |||
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| Rutherfordton | |||
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| Rutherford Hospital | |||
| James Dewitt Bearden | Ph: 800-486-5941 | ||
| North Dakota | |||
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| Bismarck | |||
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| Bismarck Cancer Center | |||
| Edward J. Wos | Ph: 701-323-5760 | ||
| Email: tfischer@mohs.org | |||
| Fargo | |||
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| Roger Maris Cancer Center at MeritCare Hospital | |||
| Preston D. Steen | Ph: 701-234-6161 | ||
| Preston D. Steen | Ph: 701-234-6161 | ||
| Sanford Clinic North-Fargo | |||
| Preston D. Steen | Ph: 701-234-6161 | ||
| Grand Forks | |||
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| Altru Cancer Center at Altru Hospital | |||
| Grant R Seeger | Ph: 701-780-6520 | ||
| Ohio | |||
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| Dayton | |||
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| CCOP - Dayton | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| David L. Rike Cancer Center at Miami Valley Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Good Samaritan Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Grandview Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Samaritan North Cancer Care Center | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Findlay | |||
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| Blanchard Valley Regional Cancer Center | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Franklin | |||
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| Atrium Medical Center | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Greenville | |||
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| Wayne Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Kettering | |||
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| Charles F. Kettering Memorial Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Troy | |||
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| UVMC Cancer Care Center at Upper Valley Medical Center | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Xenia | |||
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| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |||
| Howard M. Gross | Ph: 317-783-8918 | ||
| Oklahoma | |||
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| Tulsa | |||
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| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |||
| Alan M Keller | Ph: 918-499-2000 | ||
| Pennsylvania | |||
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| Allentown | |||
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| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |||
| Suresh G. Nair | Ph: 610-402-2273 | ||
| South Carolina | |||
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| Anderson | |||
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| AnMed Cancer Center | |||
| James Dewitt Bearden | Ph: 800-486-5941 | ||
| James Dewitt Bearden | Ph: 800-486-5941 | ||
| Spartanburg | |||
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| CCOP - Upstate Carolina | |||
| James Dewitt Bearden | Ph: 800-486-5941 | ||
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |||
| James Dewitt Bearden | Ph: 800-486-5941 | ||
| South Dakota | |||
|
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| Rapid City | |||
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| Rapid City Regional Hospital | |||
| Richard C Tenglin | Ph: 605-716-3982 | ||
| Email: research@rcrh.org | |||
| Sioux Falls | |||
|
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| Avera Cancer Institute | |||
| Addison R Tolentino | Ph: 800-657-4377 | ||
| Email: Jan.Healy@avera.org | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01156142
Information obtained from ClinicalTrials.gov on March 04, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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