Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • NRG-HN001
    NCT ID
    • NCT02135042
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II/III
    Principal Investigator

    Objective:

    Primary Objectives for Randomized Phase II and Phase III Studies:
    • Detectable Plasma EBV DNA Cohort (randomized phase II): The primary objective is to determine whether substituting adjuvant CDDP and 5-FU with gemcitabine and paclitaxel will result in superior progression-free survival
    • Undetectable Plasma EBV DNA Cohort (phase III): The primary objective is to determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in noninferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy
    Secondary Objectives for Randomized Phase II and Phase III Studies:

    To compare the following between arms:
    • Time to distant metastasis
    • Time to local progression
    • Time to regional progression
    • Progression-free survival (Undetectable Cohort)
    • Overall survival (Detectable Cohort)
    • Acute and late toxicity profiles based on clinician-reported CTCAE, v. 4
    • Death during or within 30 days of end of protocol treatment
    • Quality of life (general and physical well-being)
    • Quality of life (hearing)
    • Quality of life (peripheral neuropathy)
    • Cost effectiveness
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Bay Region

    3140 W Campus Dr.
    Bay City, MI 48706
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    Phone: 989-667-2370

    Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

    1221 South Drive
    Mt Pleasant, MI 48858
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    Phone: 989-772-6811

    Karmanos Cancer Institute at McLaren Clarkston

    5680 Bow Pointe Dr
    Clarkston, MI 48346
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    Phone: 248-922-6650

    Karmanos Cancer Institute at McLaren Flint

    4100 Beecher Rd
    Flint, MI 48532
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    Phone: 810-342-3800

    Karmanos Cancer Institute at McLaren Flint - Singh and Arora

    4100 Beecher Road
    Flint, MI 48532
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    Karmanos Cancer Institute at McLaren Greater Lansing

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Greater Lansing - Lake Lansing Road

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
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    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Macomb

    1080 Harrington Blvd
    Mount Clemens, MI 48043
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    Phone: 586-493-7500

    Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    560 W Mitchell St
    Petoskey, MI 49770
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    Phone: 231-487-3390

    Karmanos Cancer Institute at McLaren Port Huron

    1221 Pine Grove Ave
    Port Huron, MI 48060
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    Phone: 810-982-5200