Phase 2Recruiting

Comparing Computed Tomography with Neck Dissection for buccal mucosa squamous cell carcinoma

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

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

Condition: Buccal Mucosa Squamous Cell CarcinomaSponsor: NRG OncologyTarget enrollment: 686

Phase 2
2 groups
One site, in Toronto
Recruiting

Interventions (10)

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

Canadian Sites (1)

1 of 1 recruiting

University Health Network-Princess Margaret Hospital
Toronto, Ontario
Recruiting

See who this study is looking for34 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \[AJCC\] 8th edition \[ed.\]) based on the following diagnostic workup:
+Zubrod performance status 0-2 within 42 days prior to registration
+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
+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
+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
+For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration

Exclusion

−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)
−Severe, active co-morbidity that would preclude an elective or completion neck dissection
−Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted
−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)
−Currently participating in another investigational therapeutic trial
−Pregnancy and breast-feeding mothers
−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
−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
−Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 2/3 — a combined study that runs the middle stage and the large comparison stage together.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A receives one or more of: Chest Radiography, Computed Tomography, Fludeoxyglucose F-18, Imaging Agent, Planar Imaging, Positron Emission Tomography, Questionnaire Administration, Sentinel Lymph Node Biopsy and Single Photon Emission Computed Tomography.

Registry label: A: Group I (SLN biopsy)

Group B, the comparison group, receives one or more of: Chest Radiography, Fludeoxyglucose F-18, Neck Dissection, Positron Emission Tomography and Questionnaire Administration.

Registry label: B: Group II (END)

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 686 people.

The study is currently expected to finish around April 2036.

The main measurement is taken over: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Patient-reported neck and shoulder function (Phase II/III) — measured over Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery.

Patient reported quality of life (QOL) (Phase II) — measured over Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery.

Disease-free survival (DFS) (phase III) — measured over From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04333537 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?