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Trial record 1 of 1 for:    HN006
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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

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ClinicalTrials.gov Identifier: NCT04333537
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Buccal Mucosa Squamous Cell Carcinoma Floor of Mouth Squamous Cell Carcinoma Gingival Squamous Cell Carcinoma Hard Palate Squamous Cell Carcinoma Lip Squamous Cell Carcinoma Lower Alveolar Ridge Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Retromolar Trigone Squamous Cell Carcinoma Stage I Lip and Oral Cavity Cancer AJCC v8 Stage II Lip and Oral Cavity Cancer AJCC v8 Tongue Squamous Cell Carcinoma Upper Alveolar Ridge Squamous Cell Carcinoma Procedure: Computed Tomography (CT) Drug: Imaging Agent Procedure: Neck Dissection Procedure: Planar Imaging Procedure: Sentinel Lymph Node Biopsy Procedure: Single Photon Emission Computed Tomography Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : May 18, 2031
Estimated Study Completion Date : May 18, 2036


Arm Intervention/treatment
Experimental: Sentinel Lymph Node (SLN) Biopsy
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
Procedure: Computed Tomography (CT)
Undergo SPECT/CT scan
Other Names:
  • CAT
  • CAT scan
  • Computed Tomography
  • computerized axial tomography
  • Computerized Tomography
  • CT
  • CT scan
  • tomography

Drug: Imaging Agent
Receive imaging agent via injection
Other Name: Image Enhancement Agent

Procedure: Planar Imaging
Undergo planar imaging

Procedure: Sentinel Lymph Node Biopsy
Undergo SLN biopsy
Other Names:
  • Sentinel Node Biopsy
  • Sentinel node biopsy alone
  • SLNB
  • SNB

Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT scan
Other Names:
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon

Active Comparator: Elective Neck Dissection (END)
Patients undergo standard END.
Procedure: Computed Tomography (CT)
Undergo SPECT/CT scan
Other Names:
  • CAT
  • CAT scan
  • Computed Tomography
  • computerized axial tomography
  • Computerized Tomography
  • CT
  • CT scan
  • tomography

Procedure: Neck Dissection
Undergo standard elective neck dissection




Primary Outcome Measures :
  1. Patient-reported neck and shoulder function (Phase II/III) [ Time Frame: From Baseline (Before surgery) to 6 months post-surgery ]
    Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point (change from Baseline to 6 months) between arm difference is clinically meaningful. The hypothesis of no between-arm difference in 6-month NDII scores will be tested using the ANCOVA model at one-sided significance level of 0.10. Point estimates and 95% confidence intervals (CIs) for the mean NDII scores at 6 months for each treatment arm and for the between-arm difference at 6-months based on the proposed model will be provided.

  2. Disease-Free Survival [ Time Frame: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years ]
    An event for disease-free survival is local recurrence, regional recurrence, distant metastasis, or death due to any cause. Disease-free survival time is randomization date to the date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization to death due to any cause, assessed up to 11 years ]
    An event for overall survival is death due to any cause. Overall survival time is randomization date to date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

  2. Loco-regional Failure [ Time Frame: From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years ]
    An event for local-regional failure is local or regional recurrence. Local-regional failure time is randomization date to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between arm differences compared using cause-specific log-rank test.

  3. Distant metastasis [ Time Frame: From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years ]
    An event is the occurrence of distant metastasis. Distant metastasis time is randomization to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between-arm differences compared using cause-specific log-rank test.

  4. Patient-reported shoulder-related QOL, function impairment and disability [ Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
    Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.

  5. General quality of life [ Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
    Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index (FACT-TOI) scores on a scale from 0-96. A higher score indicates better quality of life.

  6. Nodal metastasis detection rate [ Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint. ]
    Defined as the proportion of patients with pathologic positive nodes using the pathology results.

  7. Pathologic false omission rate [ Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint. ]
    Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.

  8. Post-surgery patient-reported outcome [ Time Frame: At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
    Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION INCLUSION:
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration
  • Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC] 8th edition [ed.]) based on the following diagnostic workup:

    • History/physical examination within 42 days prior to registration
    • Imaging of head and neck within 42 days prior to registration

      • PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; CT portion of the PET/CT must be of diagnostic quality
      • Chest imaging with either a chest x-ray, CT chest scan (with or without contrast) or PET/CT (with or without contrast) within 42 days prior to registration
  • Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)

    • Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins
  • Zubrod performance status 0-2 within 42 days prior to registration
  • For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Only English-speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
  • PRIOR TO STEP 2 RANDOMIZATION:
  • FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be submitted for central review. However, if the FDG PET/CT is not of diagnostic quality, then FDG PET/CT will have to be repeated prior to Step 2 registration

    • PET/CT node negative patients, determined by central read, will proceed to randomization.
    • PET/CT positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development

      • NOTE: All FDG PET/CT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)

Exclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION EXCLUSION:
  • Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
  • Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years
  • Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
  • Unable or unwilling to complete NDII (baseline only)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
  • Pregnancy and breast-feeding mothers
  • Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted
  • Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy
  • Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia [CLL]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection)
  • Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
  • Currently participating in another investigational therapeutic trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333537


Locations
Show Show 58 study locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephen Y Lai NRG Oncology
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT04333537    
Other Study ID Numbers: NRG-HN006
NCI-2020-01542 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-HN006 ( Other Identifier: NRG Oncology )
NRG-HN006 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck
Lip Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases