Comparing Sentinel Lymph Node (SLN) Biopsy with Standard Neck Dissection for Patients with Early-Stage Oral Cavity Cancer

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT04333537
Trial Phases:	Phase II Phase III	Protocol IDs:	NRG-HN006 (primary) NRG-HN006 NCI-2020-01542
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT04333537

Summary

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

Objectives

PRIMARY OBJECTIVES:
I. 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 II)
II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)
III. 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). (Phase III)

SECONDARY OBJECTIVES:
I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
II. To measure and compare overall survival (OS) between surgical arms.
III. To measure and compare the toxicity of the two surgical arms.
IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms using the following instruments:
IVa. Neck Dissection Impairment Index (NDII);
IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH);
IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N).
V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
VII. To assess nodal metastases rates between arms.
VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
IX. To determine if patient-reported neck and shoulder function using the NDII and related QOL at 6 months after surgery with SLN biopsy is superior to the END in low-risk patients.
X. To compare the diagnostic performance of planar only versus (vs.) single photon emission computed tomography (SPECT)/CT plus planar for SLN mapping (phase II only).

EXPLORATORY OBJECTIVES:
I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms.
II. To collect biospecimens for future translational science studies.
III. To assess the DFS between arms in low-risk patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.

GROUP II: Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.

After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

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