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
  • A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • NRG-HN005
    NCT ID
    • NCT03952585
    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 Objective:
    Phase II
    • To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Phase III
    • To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Secondary Objectives:
    • To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm;
    • To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm;
    • To determine acute and late toxicity profiles as measured by the CTCAE;
    • To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE;
    • To compare changes in patient-reported outcomes (HHIA-S, EORTC-QLQ30) between each experimental arm and the control arm;
    • To assess the association of FDG-PET/CT at baseline with locoregional control and PFS;
    • To estimate the negative predictive value of the 12-14 weeks post-RT FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
  • 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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    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 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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    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
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    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