Phase II Study for p16+ Oropharyngeal Cancer at University of Michigan (CuSToMIze)
This study, called CuSToMIze, is for people with early-stage oropharyngeal cancer (cancer of the middle part of the throat, including tonsils and base of tongue) that is positive for p16 (a protein often linked to HPV). It's testing two ways to treat this cancer: either surgery followed by observation or radiation (with or without chemotherapy), or a personalized approach using chemoradiation (a combination of chemotherapy and radiation). The goal is to see how well these treatments prevent the cancer from returning in the treated area. You may be eligible if you are 18 or older, have specific types of oropharyngeal cancer, and your cancer shows up on a PET scan and is p16 positive. The study plans to enroll 150 participants.
- Study design
- This is a single-center, non-randomized Phase II study. It aims to enroll 150 participants with Stage I-II p16+ oropharyngeal cancer.
- What's involved
- Participants in Cohort A will undergo initial surgery and neck dissection. Depending on pathology results, they may then receive observation, post-operative radiation, or chemoradiation. Patients receiving chemoradiation will have a mid-treatment PET/CT scan to guide further radiation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, loco-regional recurrence free survival, will be measured at 2 years after treatment.
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NCT05894083
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Michigan Rogel Cancer CenterInvestigator-initiated
~150 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:SurgeryChemoradiationObservationPost-operative radiation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Loco-regional recurrence free survival (LR-RFS) rate
Measured over 2 years
Conditions
Where it's being run
1 sites across 1 statesMichigan1
Study leadership
- Michelle A Mierzwa · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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;
Age ≥ 18;
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
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.
What this trial measures
- Loco-regional recurrence free survival (LR-RFS) rate2 years
LR-RFS is defined as the difference between the date of the first treatment to the date of the first of the following events: death (any cause) or loco-regional progression. LR-RFS rates will be reported using Kaplan Meier (KM) estimates at 2 years.