Los Angeles, CANCT07441681Now EnrollingIRB Ready

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Trial in Los Angeles, CA

Access cutting-edge clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 treatment through this phase 3 clinical trial at a research site in Los Angeles. Study-provided care at no cost to qualified participants.

Sponsored by NRG Oncology

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Expert Care in Los Angeles

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

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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 Los Angeles, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Los Angeles

    Convenient for CA 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 Los Angeles site if eligible
  4. 4Begin participation

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

This phase III trial compares cetuxumab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetxiumab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with head and neck cancer who are unable to receive cisplatin.

Sponsor: NRG Oncology

Who Can Participate

Inclusion Criteria

Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity
Local evaluation of p16 status is required for all oropharynx patients prior to registration
Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration
Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:
Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 8th edition stage III-IVB
Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:
AJCC 8th Edition TNM: T3-4b N0 M0 AJCC 8th Edition Stage: III-IVB
AJCC 8th Edition TNM: T1-4b N1-3 M0 AJCC 8th Edition Stage: III-IVB
p16-positive oropharynx cancer: AJCC 8th edition stage III and selected stage I-II based on smoking status in pack-years
Eligible p16-Positive Oropharyngeal Primaries
AJCC 8th Edition TNM: T1-2 N1 M0 AJCC 8th Edition Stage: I Pack-Years: \> 10
AJCC 8th Edition TNM: T1-2 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any
AJCC 8th Edition TNM: T3 N0-1 M0 AJCC 8th Edition Stage: II Pack-Years: \> 10
AJCC 8th Edition TNM: T3 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any
AJCC 8th Edition TNM: T1-3 N3 M0 AJCC 8th Edition Stage: III Pack-Years: any
AJCC 8th Edition TNM: T4 N0-3 M0 AJCC 8th Edition Stage: III Pack-Years: any
Note: Number of pack-years = \[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\] / 20
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation
The following are required prior to registration:
Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)
Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT
Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form in Oncology Patient Enrollment Network (OPEN)
Patients must have a contraindication to cisplatin as defined in the following bullet points:
Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration:
Creatinine clearance (CrCl) \< 60 mL/min by the Cockroft-Gault formula
Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0)
History of hearing loss, defined as either:
Existing need of a hearing aid OR
≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR
age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \< 0.80 prior to registration OR
Age \< 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions):
HNCIG omega score \< 0.80
(Modified) Charlson Comorbidity Index (CCI) ≥ 1
G-8 score ≤ 14
Not pregnant and not nursing
Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines
No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
No prior surgery for the study cancer

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 (NCT07441681) 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.

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Treatment Options in Los Angeles, CA

If you're searching for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 treatment options in Los Angeles, CA, this clinical trial (NCT07441681) 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 3 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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