Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04333537
Other study ID # NRG-HN006
Secondary ID NCI-2020-01542NR
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 8, 2020
Est. completion date May 18, 2036

Study information

Verified date February 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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/computed tomography (PET/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 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. 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 single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy. GROUP II: Patients undergo standard END. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 618
Est. completion date May 18, 2036
Est. primary completion date May 18, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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; diagnostic quality CT is preferred and highly recommended for the PET/CT when possible. - Imaging of chest within 42 days prior to registration; chest x-ray, CT chest scan (with or without contrast) or PET/CT (with or without contrast) - 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 patients who are 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. - PET/CT node negative patients, determined by central read, will proceed to randomization. - PET/CT node 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) - The patient must complete NDII prior to step 2 registration 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography (CT)
Undergo SPECT/CT scan
Drug:
Imaging Agent
Receive imaging agent via injection
Procedure:
Neck Dissection
Undergo standard elective neck dissection
Planar Imaging
Undergo planar imaging
Sentinel Lymph Node Biopsy
Undergo SLN biopsy
Single Photon Emission Computed Tomography
Undergo SPECT/CT scan

Locations

Country Name City State
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Boston Medical Center Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States MD Anderson in The Woodlands Conroe Texas
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Geisinger Medical Center Danville Pennsylvania
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States City of Hope Comprehensive Cancer Center Duarte California
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Michael E DeBakey VA Medical Center Houston Texas
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Kansas Cancer Center Kansas City Kansas
United States UC San Diego Moores Cancer Center La Jolla California
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States MD Anderson League City League City Texas
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Methodist Hospital Memphis Tennessee
United States University of Tennessee Health Science Center Memphis Tennessee
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States NYU Winthrop Hospital Mineola New York
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Lenox Hill Hospital New York New York
United States Manhattan Eye Ear and Throat Hospital New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Stanford Cancer Center South Bay San Jose California
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States MD Anderson in Sugar Land Sugar Land Texas
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Memorial Sloan Kettering Nassau Uniondale New York
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported neck and shoulder function (Phase II/III) 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. From Baseline (Before surgery) to 6 months post-surgery
Primary Disease-Free Survival 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. From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Secondary Overall Survival 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. From randomization to death due to any cause, assessed up to 11 years
Secondary Loco-regional Failure 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. 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
Secondary Distant metastasis 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. 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
Secondary Patient-reported shoulder-related QOL, function impairment and disability Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability. Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Secondary General quality of life 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. Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Secondary Nodal metastasis detection rate Defined as the proportion of patients with pathologic positive nodes using the pathology results. During surgery. Analysis occurs at the same time as the primary endpoint.
Secondary Pathologic false omission rate Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients. During surgery. Analysis occurs at the same time as the primary endpoint.
Secondary Post-surgery patient-reported outcome Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model. At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint.
See also
  Status Clinical Trial Phase
Completed NCT03650699 - Biofeedback Rehabilitation to Improve Speaking and Eating in Public N/A
Recruiting NCT05098119 - Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002) Phase 2
Terminated NCT03053960 - Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer
Recruiting NCT05876247 - Articulatory Adaptation Following Oral Cancer Treatment
Completed NCT03618654 - Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma Early Phase 1
Recruiting NCT04801472 - Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM) N/A
Recruiting NCT04858269 - First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients Phase 2
Active, not recruiting NCT03529604 - Salivary Ap4A, SCCA, TROP2 in Oral Cancer Patients
Completed NCT03028766 - WEE1 Inhibitor With Cisplatin and Radiotherapy: A Trial in Head and Neck Cancer Phase 1
Recruiting NCT05681039 - Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC). Phase 2
Completed NCT03510390 - Metformin in Head and Neck Squamous Cell Carcinoma: Effect on Tissue Oxygenation N/A
Recruiting NCT05578170 - Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
Recruiting NCT05950737 - Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience N/A
Recruiting NCT03727594 - Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
Terminated NCT02582008 - Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy Early Phase 1
Recruiting NCT05749042 - A Study of Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients With Advanced Oral Cavity Squamous Cell Carcinoma Phase 2
Recruiting NCT06097468 - Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC) Phase 1/Phase 2
Withdrawn NCT04892875 - A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers Phase 1
Active, not recruiting NCT03784066 - Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity Phase 1/Phase 2
Active, not recruiting NCT03381183 - IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma Phase 1