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  • 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
    • John
      Cramer, M.D.

      Ear Nose & Throat (Otolaryngology), Oncology - Surgical View Profile

    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).

    Primary Objectives 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 Weisberg Cancer Center - Farmington Hills

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