Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
概览
- 阶段
- 2 期
- 干预措施
- Neck Dissection
- 疾病 / 适应症
- Buccal Mucosa Squamous Cell Carcinoma
- 发起方
- NRG Oncology
- 入组人数
- 686
- 试验地点
- 174
- 主要终点
- Patient-reported neck and shoulder function (Phase II/III)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •PRIOR TO STEP 1 REGISTRATION INCLUSION:
- •Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) 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 as part of 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
排除标准
- •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 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 different cancer(s) is allowable
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •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
研究组 & 干预措施
Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Neck Dissection
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Chest Radiography
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Computed Tomography
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Fludeoxyglucose F-18
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Imaging Agent
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Planar Imaging
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Positron Emission Tomography
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Questionnaire Administration
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Sentinel Lymph Node Biopsy
Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Single Photon Emission Computed Tomography
Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Chest Radiography
Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Fludeoxyglucose F-18
Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Positron Emission Tomography
Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
干预措施: Questionnaire Administration
结局指标
主要结局
Patient-reported neck and shoulder function (Phase II/III)
时间窗: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after 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 between arm difference in the 6-month post-surgery NDII scores is clinically meaningful.
Patient reported quality of life (QOL) (Phase II)
时间窗: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
Will be measured using 3 questionnaires over 12-15 minutes.
Disease-free survival (DFS) (phase III)
时间窗: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Measured using Cox proportional hazards model and the Kaplan-Meier method. Failure includes local/regional recurrence, distant metastasis, or death due to any cause.
次要结局
- Overall survival rate(From randomization to death due to any cause, assessed up to 11 years)
- Loco-regional failure(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)
- Distant metastasis(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)
- Toxicity(Time of primary endpoint analysis)
- Patient-reported shoulder-related QOL, function impairment and disability(Baseline, 3 weeks, 3, 6, 12 months post-surgery)
- General quality of life(Baseline, 3 weeks, 3, 6, 12 months post-surgery)
- Nodal metastasis detection rate(At time of surgery)
- Pathologic false omission rate(At time of surgery)
- Length of hospital stay(Prior to surgery, at time of discharge from surgery)
- Post-surgery patient-reported outcome(At 6 months post-surgery)
- Diagnostic performance (Phase II only)(Up to 11 years)