Columbus, OHNCT06323460Now EnrollingIRB Ready

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Trial in Columbus, OH

Access cutting-edge clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 treatment through this phase 2 clinical trial at a research site in Columbus. Study-provided care at no cost to qualified participants.

Sponsored by Ohio State University Comprehensive Cancer Center

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Expert Care in Columbus

Access clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 treatment provided free

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Check if you qualify for this clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 clinical trial in Columbus, OH

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Why Participate?

  • No-Cost Study Care

  • Local to Columbus

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Columbus site if eligible
  4. 4Begin participation

About This Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Study in Columbus

This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.

Sponsor: Ohio State University Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of the primary tumor is not feasible
P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur prior to trial enrollment
Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer \[AJCC\] 8th edition) including no evidence of distant metastases based on general history, imaging, physical examination, and examination with laryngopharyngoscopy
Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without removal of nodal disease is permitted, as is excision of gross nodes but with intact primary site
Fludeoxyglucose F-18 (FDG) PET/CT from the base of skull to the mid-thigh is mandatory and patients cannot be enrolled without a pretreatment PET/CT. PET/CT must be completed prior to enrollment
Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma cell free DNA value of \>= 200 copies/mL at baseline
Patients must provide their smoking history prior to enrollment. Patients must have =\< 10 pack years of smoking. The number of pack years will be calculated using the following formula: Frequency of smoking (cigarettes/day) x duration of cigarette smoking (years)/20
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Absolute neutrophil count: ≥ 1500/mcL (within 14 days prior to registration)
Platelets: \>= 100,000/mcL (within 14 days prior to registration)
Hemoglobin \>= 8.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration)
Total bilirubin \>= 1.5 x institutional upper limit of normal (within 14 days prior to registration)
Aspartate transaminase (AST) or alanine transaminase (ALT) \>= 3.0 x institutional upper limit of normal (within 14 days prior to registration)
Serum creatinine =\< 1.5 x institutional upper limit of normal or creatinine clearance \>= 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to registration)
Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
Patients with known positive hepatitis B surface antigen indicating acute or chronic infection would make patient ineligible unless viral load becomes undetectable on suppressive therapy
Patients with history of hepatitis C virus must have been treated and cured
For women of childbearing potential, negative serum or urine pregnancy test within 14 days of registration
Patient or legally authorized representative must provide study specific informed consent prior to study entry

Exclusion Criteria

Recurrent disease
Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles
Cancers from an oral cavity site, even if p16 positive
Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers
Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
Prior systemic chemotherapy or immunotherapy
Prior radiotherapy that would result in overlap of radiation fields
Severe active co-morbidity defined as: Unstable angina or congestive heart failure requiring hospitalization in the last 6 months. Condition requiring systemic treatment with steroids or immunosuppressive medications within 14 days of registration
Patients with active autoimmune disease requiring systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs
Patients who are pregnant, nursing, or expected to conceive or father children
Patients who are allergic to cisplatin, carboplatin, or paclitaxel

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 Columbus?

Yes, this clinical trial (NCT06323460) has an active research site in Columbus, OH 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.

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Treatment Options in Columbus, OH

If you're searching for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 treatment options in Columbus, OH, this clinical trial (NCT06323460) 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 Columbus research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 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 clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 clinical trials near you to find additional studies recruiting in your area.

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