Is NCT05307939 recruiting in Middletown, NJ?

Yes, NCT05307939 is currently recruiting participants at its Middletown, NJ location. This oropharynx cancer clinical trial is actively enrolling qualified participants.

How do I join the oropharynx cancer clinical trial in Middletown?

To join this clinical trial in Middletown, 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 Middletown 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.

Oropharynx Cancer Clinical Trial in Middletown, NJ

About This Oropharynx Cancer Study in Middletown

This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.

HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.

Surgical resection of all gross disease with no gross disease visualized on post-operative imaging. o For patients with pT0 (unknown primary) evaluation for the primary should include PET/CT, direct laryngoscopy, ipsilateral tonsillectomy, and targeted biopsy. This should be followed by a neck dissection.

Two, undetectable (\<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).

A minimum of one of the following pathologic criteria: (Arm A)

AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3

AJCC 7 ≥pN2

Lymphovascular invasion

Perineural invasion

Close pathologic margin (≤ 3 mm)

Signed informed consent form by the participant or their legally authorized representative (LAR).

A minimum of one of the following pathologic criteria (Arm B):

Microscopic positive margin

Extracapsular extension

Signed informed consent form by the participant or their legally authorized representative (LAR). Additional criteria for Arm B only:

Adequate hematologic function within 30 days prior to registration, defined as follows:

White Blood Count (WBC) ≥ 2 K/mcL

Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

Platelets ≥ 100,000 cells/mm3

Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable

Adequate renal function within 30 days prior to registration, defined as follows:

Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:

CCr male = \[(140 - age) x (wt in kg)\] divided by \[(Serum Cr mg/dl) x (72)\]

CCr female = 0.85 x (CrCl male)

Adequate hepatic function within 30 days prior to registration, defined as follows: \- Bilirubin \< 2 mg/dl o AST or ALT \< 3 x the upper limit of normal

Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

Exclusion Criteria

Metastatic disease

Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)

Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI

Prior head and neck radiation

Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL

Subjects with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside of the oropharynx if determined by the PI/Co-PI, then the patient can proceed with protocol activities

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater o Note: Exceptions can be made for patients with prior invasive malignancy if determined by the PI/Co-PI, then the patient can proceed with protocol activities

Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable

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 registration

Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration

Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.

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 Middletown?

Yes, this clinical trial (NCT05307939) has an active research site in Middletown, 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.

Oropharynx Cancer Treatment Options in Middletown, NJ

If you're searching for oropharynx cancer treatment options in Middletown, NJ, this clinical trial (NCT05307939) 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 Middletown research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced oropharynx 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 oropharynx cancer clinical trials near you to find additional studies recruiting in your area.

Oropharynx Cancer Clinical Trial in Middletown, NJ

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