Is NCT05894083 recruiting in Ann Arbor, MI?

Yes, NCT05894083 is currently recruiting participants at its Ann Arbor, MI location. This oropharyngeal cancer clinical trial is actively enrolling qualified participants.

How do I join the oropharyngeal cancer clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, 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 Ann Arbor 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 Ann Arbor, MI

About This Oropharyngeal Cancer Study in Ann Arbor

Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).

Sponsor: University of Michigan Rogel Cancer Center

Who Can Participate

Inclusion Criteria

Patients must have FDG-avid (maximum SUV ≥ 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) or unknown primary that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization

Clinical stage: Stage I-II AJCC 8th edition staging

Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

History/physical examination, including documentation of weight within 4 weeks prior to registration;

For Cohort B, FDG-PET/CT scan for staging within 6 weeks prior to registration. For Cohort A, acceptable imaging for staging can include diagnostic CT neck/chest or PET-CT within 6 weeks prior to registration

Zubrod Performance Status 0-1 within 4 weeks prior to registration;

Able to tolerate PET/CT imaging required to be performed

For Cohort A, tumors must be potentially surgically resectable via a transoral approach, at the discretion of the treating surgeon. Additionally, they must have 0-2 clinically positive LNs on diagnostic CT or PET-CT according clinical consensus of the treatment team

For both cohorts, CBC required within 4 weeks prior to registration. For Cohort B, CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;

Platelets ≥ 100,000 cells/mm3;

Hemoglobin ≥ 8.0 g/dL

Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration.

Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.

The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria

cT4, cN3, or cM1 disease (also explained as AJCC 8th edition clinical staging,)

Patients with radiographic ECE or matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread.

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);

Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \>3 years prior to study;

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;

Prior allergic reaction or hypersensitivity reactions to paclitaxel, carboplatin or other platinum containing products. This also includes patients with a history of severe hypersensitivity reaction to products containing Cremophor EL.

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 3 months;

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

Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;

Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.

Severe bone marrow depression or significant bleeding

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

For Cohort B, poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite 2 attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians.

Active enrollment on another clinical trial involving active treatment 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 Ann Arbor?

Yes, this clinical trial (NCT05894083) has an active research site in Ann Arbor, MI 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 Ann Arbor, MI

If you're searching for oropharyngeal cancer treatment options in Ann Arbor, MI, this clinical trial (NCT05894083) 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 Ann Arbor 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 Ann Arbor, MI

Expert Care in Ann Arbor

IRB Approved

No-Cost Care

Apply for This Ann Arbor Location

Why Participate?

Simple Process