Идёт набор NCT04333537

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

Фаза II / Фаза III С лечением Buccal Mucosa Squamous Cell Carcinoma Floor of Mouth Squamous Cell Carcinoma Gingival Squamous Cell Carcinoma Hard Palate Squamous Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Chest Radiography, Computed Tomography, Fludeoxyglucose F-18, Imaging Agent.
Кому может быть актуально: Состояния в реестре: Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Chest Radiography
Undergo chest x-ray
Процедура Computed Tomography
Undergo SPECT/CT scan and FDG PET/CT or CT
Другое Fludeoxyglucose F-18
Undergo FDG PET/CT
Препарат Imaging Agent
Receive imaging agent via injection
Процедура Neck Dissection
Undergo standard elective neck dissection
Процедура Planar Imaging
Undergo planar imaging
Процедура Positron Emission Tomography
Undergo FDG PET/CT
Другое Questionnaire Administration
Ancillary studies
Процедура Sentinel Lymph Node Biopsy
Undergo SLN biopsy
Процедура Single Photon Emission Computed Tomography
Undergo SPECT/CT scan

Первичные конечные точки

Patient-reported neck and shoulder function (Phase II/III) [Срок оценки: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery]
Patient reported quality of life (QOL) (Phase II) [Срок оценки: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery]
Disease-free survival (DFS) (phase III) [Срок оценки: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years]

Вторичные конечные точки (11)

Overall survival rate [Срок оценки: From randomization to death due to any cause, assessed up to 11 years]
Loco-regional failure [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Time of primary endpoint analysis]
Patient-reported shoulder-related QOL, function impairment and disability [Срок оценки: Baseline, 3 weeks, 3, 6, 12 months post-surgery]
General quality of life [Срок оценки: Baseline, 3 weeks, 3, 6, 12 months post-surgery]
Nodal metastasis detection rate [Срок оценки: At time of surgery]
Pathologic false omission rate [Срок оценки: At time of surgery]
Length of hospital stay [Срок оценки: Prior to surgery, at time of discharge from surgery]
Post-surgery patient-reported outcome [Срок оценки: At 6 months post-surgery]
Diagnostic performance (Phase II only) [Срок оценки: Up to 11 years]

Критерии участия

Критерии включения

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 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

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