Is NCT04333537 recruiting in Duarte, CA?

Yes, NCT04333537 is currently recruiting participants at its Duarte, CA location. This buccal mucosa squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Buccal Mucosa Squamous Cell Carcinoma Clinical Trial in Duarte, CA

Q: How do I join the buccal mucosa squamous cell carcinoma clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Buccal Mucosa Squamous Cell Carcinoma Study in Duarte

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.

Sponsor: NRG Oncology

Who Can Participate

Inclusion 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 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

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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT04333537) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Buccal Mucosa Squamous Cell Carcinoma Treatment Options in Duarte, CA

If you're searching for buccal mucosa squamous cell carcinoma treatment options in Duarte, CA, this clinical trial (NCT04333537) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced buccal mucosa squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all buccal mucosa squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Buccal Mucosa Squamous Cell Carcinoma Clinical Trial in Duarte, CA

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