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/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • NRG-HN006
    NCT ID
    • NCT04333537
    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 Phase II:
      To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with Sentinel Lymph Node (SLN) biopsy compared to Elective Neck Dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).
    Phase III:
    • To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
    • To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
    Secondary Objectives
    • To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
    • To measure and compare overall survival (OS) between surgical arms.
    • To measure and compare the toxicity of the two surgical arms.
    • To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
      • Neck Dissection Impairment Index (NDII)
      • Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH)
      • Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)
    • To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
    • To estimate the negative predictive rate of FDG PET/CT for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
    • To assess nodal metastases rates between arms.
    • To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
    • To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.
  • 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