Is NCT05419089 recruiting in Paramus, NJ?

Yes, NCT05419089 is currently recruiting participants at its Paramus, NJ location. This oropharyngeal cancer clinical trial is actively enrolling qualified participants.

How do I join the oropharyngeal cancer clinical trial in Paramus?

To join this clinical trial in Paramus, 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 Paramus 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 Paramus, NJ

About This Oropharyngeal Cancer Study in Paramus

The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetect

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in \> 70% of tumor cells. Immunohistochemistry must be performed or reviewed at the central laboratory. P16 status may be determined prior to consent and must be confirmed by surgical specimen if a biopsy is unavailable. HR-HPV status and postoperative cfHPVDNA testing must be performed and resulted prior to treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.

Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments/mL and is required for inclusion in the trial.

Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment assignment. Undetectable cfHPVDNA is defined as \< 5 fragments/mL.

AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension.

Age ≥ 18 years at screening

No previous surgery, radiation therapy, or chemotherapy for head and neck cancer (other than excision/incisional biopsy of the primary site, excisional/incisional nodal biopsy, or tonsillectomy) is allowed at time of study entry.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

No active tobacco use (≥1cigarette or cigarette-equivalent per day within the last 5 years) and no cumulative smoking history of \>20 pack years. 1 cigar = 4 cigarette-equivalent exposure

Ability to understand and the willingness to sign a written informed consent document.

Participants must have adequate bone marrow, hepatic and renal functions as defined below:

Platelet count ≥ 90 x 109/l.

Hemoglobin ≥ 10 g/dl (may achieve by transfusion).

Renal function: eGFR ≥ 50 ml/min

Exclusion Criteria

Age \< 18 years at screening

Pregnant or breast-feeding women.

Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery/radiotherapy, ductal carcinoma in situ of the breast treated with surgery/radiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years.

Other serious illnesses or medical conditions including but not limited to:

Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.

History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures

Active clinically significant uncontrolled infection

Active peptic ulcer disease defined as unhealed or clinically active

Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis

Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis.

Prior organ transplant

Interstitial lung disease

Concurrent treatment with any other anti-cancer therapy

Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol.

Active hepatitis C by history

Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \> 3 unequivocally radiographic pathologic cervical nodes.

Non-HR-HPV subtype on initial biopsy or final pathology.

5 or more positive nodes, irrespective of size, on final pathology.

p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.

Undetectable or \< 10 fragments/mL baseline cfHPVDNA prior to surgery.

Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.

Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \> 5 fragments/mL.

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 Paramus?

Yes, this clinical trial (NCT05419089) has an active research site in Paramus, NJ 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 Paramus, NJ

If you're searching for oropharyngeal cancer treatment options in Paramus, NJ, this clinical trial (NCT05419089) 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 Paramus 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 Paramus, NJ

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