Is NCT06445114 recruiting in Los Angeles, CA?

Yes, NCT06445114 is currently recruiting participants at its Los Angeles, CA location. This oropharyngeal cancer clinical trial is actively enrolling qualified participants.

How do I join the oropharyngeal cancer clinical trial in Los Angeles?

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

Is participation in this Los Angeles 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.

Oropharyngeal Cancer Clinical Trial in Los Angeles, CA

Who Can Participate

Inclusion Criteria

AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.

For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.

p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.

Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.

Have undergone or will undergo neck dissection.

Have at least one of the following after surgery:

Pathologic stage T3

2 or more positive lymph nodes

At least one lymph node \>3cm

Contralateral lymph node involvement

Lymphovascular invasion

Perineural invasion

Extranodal extension

Close/positive margins: Close margins are considered ≤3mm from the peripheral margins and ≤1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.

Patients consented preoperatively are required to have detectable cTTMV-HPV DNA based on pre-operative NavDx testing. For patients consented post-operatively, NavDx testing should be performed on the tumor tissue to ensure detectable HPV DNA and for HPV subtyping.

Age ≥ 18 years old

ECOG performance status 0 or 2 within 56 days of start of chemoradiation.

Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Adequate hematologic and renal function within 56 days of start of chemoradiation, defined as:

Hemoglobin ≥ 9.0 g/dL

Platelets ≥ 100, 000 cells/mm3

ANC ≥ 1.5 X 109/L

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

Aspartate aminotransferase/alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN)

Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 mL/min estimated using the following Cockcroft-Gault equation

Exclusion Criteria

AJCC 8th edition pT4 or cN3 disease.

Radiologic or clinical evidence of distant metastasis.

Recurrent disease.

Inability to achieve gross total resection at time of surgery.

Greater than 56 days (8 weeks) after surgical resection of the primary site.

Prior radiation to the head and neck \> 30 Gy.

Prior active invasive (not in situ) malignancy within the prior 2 years, excluding cutaneous basal cell or squamous cell carcinoma, low or intermediate risk prostate cancer, papillary thyroid cancer, stage T1aN0 kidney cancer, low-grade T1-2N0 salivary cancer, AJCC 8th edition stage I-II breast cancer, well-differentiated neuroendocrine tumors (e.g., carcinoid tumors), low grade non-Hodgkin lymphoma, or Stage 0, I, and III cutaneous melanomas. Patients with synchronous or multifocal oropharyngeal cancers are not excluded, as long as at least one of these tumors meet inclusion criteria for the trial.

Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

Transmural myocardial infarction within the last 6 months

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment

Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects

Moderate to severe hearing loss.

Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression.

Pregnant or breast-feeding women.

Prior allergic reaction to cisplatin.

Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.

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 Los Angeles?

Yes, this clinical trial (NCT06445114) has an active research site in Los Angeles, 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.

Oropharyngeal Cancer Treatment Options in Los Angeles, CA

If you're searching for oropharyngeal cancer treatment options in Los Angeles, CA, this clinical trial (NCT06445114) 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 Los Angeles research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced oropharyngeal cancer 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 oropharyngeal cancer clinical trials near you to find additional studies recruiting in your area.

Oropharyngeal Cancer Clinical Trial in Los Angeles, CA

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