Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- NRG Oncology
- 入组人数
- 686
- 试验地点
- 169
- 主要终点
- Patient-reported neck and shoulder function (Phase II/III)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Age >= 18
- •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 or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages
- •PRIOR TO STEP 2 RANDOMIZATION:
- •FDG PET/CT required prior to step
- •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
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
- •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 (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 (e.g., sarcoidosis or untreated mycobacterial infection)
- •Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
- •Currently participating in another investigational therapeutic trial
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: Positron Emission Tomography (Procedure)
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 (Procedure)
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 (Drug)
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 (Procedure)
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 (Procedure)
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 (Procedure)
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 (Other)
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 (Other)
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 (Procedure)
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 (Other)
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 (Procedure)
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 (Procedure)
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 (Procedure)
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 (Other)
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)