BridgeMD
Compares treatment options 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
ClinicalTrials.gov ID: NCT04333537
What this study is testing
What is Imaging Agent?
Imaging Agent is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for buccal mucosa squamous cell carcinoma.
Also referred to as Image Enhancement Agent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
+ 64 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Duarte, California, United States and 78 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.