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Oropharyngeal CancerPhase 2NCT05894083

A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)

A Phase 2 study testing Surgery, Chemoradiation and Observation in people with Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgery, Chemoradiation and Observation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
27 Apr 2023to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Michelle Mierzwa, MD

    Recruiting

Other trials in United States

About this study

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).

Being tested
Surgery, Chemoradiation, Observation, Post-operative radiation
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.

  • ChemoradiationCombination product

    Patients will receive an initial plan with a single prescription of 30 Gy in 15 fractions to PTV_High and PTV_Low with RT given once daily, 5 days a week (Monday through Friday). After analysis of mid-treatment PET/CT, the remaining radiation treatment will be delivered as a conedown to the gross disease only. Patients will be planned to receive a total dose of 70 Gy, 54 Gy, or 44 Gy to PTV_High in 2 Gy per fraction.

  • ObservationOther

    Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.

  • Post-operative radiationRadiation

    Patients will receive adjuvant radiation based on pathologic features.Total radiation treatment doses and prescriptions will include 36 Gy in 18 fractions, 50 Gy in 25 fractions and 60 Gy in 30 fractions.

Study groups in NCT05894083
Study groupRoleWhat they receive
SurgeryActive comparatorSurgery followed by risk-adjusted adjuvant treatment (observation, radiation, or chemoradiation).
Receives: Procedure: Surgery; Combination Product: Chemoradiation; Other: Observation; Radiation: Post-operative radiation
Definitive CRTExperimentalRisk-adjusted definitive chemoradiation.
Receives: Combination Product: Chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loco-regional recurrence free survival (LR-RFS) rate

    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.

    Measured: 2 years

Secondary outcomes (6)

  1. Progression free survival (PFS) rate

    PFS is defined as the difference between the date of the first therapy to the date of the first of the following events: death (any cause) or disease progression (local, regional, distant, defined as per section 7.1). PFS data will be censored on the date of the last tumor assessment on study for subjects who do not have objective tumor progression and who do not die while on study.

    Measured: 2 years

  2. Disease specific survival (DSS) rate

    DSS is defined as the difference between the date of the first treatment intake to the date of death due to oropharyngeal cancer.

    Measured: 2 years

  3. Overall survival (OS) rate

    OS is defined as the difference between the date of the first treatment intake to the date of death (any cause).

    Measured: 2 years

  4. Patterns of failure (locoregional relapse versus distant)

    Defined as the proportion of patients who progressed in any location and whether the first progression was local, regional or distant or in multiple locations.

    Measured: 2 years

  5. Acute toxicity

    Defined as the proportion of patients with available toxicity data and the proportion of all treated patients through cumulative incidence estimates with death treated as a competing risk and censoring for patients lost to follow-up (FU).

    Measured: up to 3 months post definitive treatment completion {section 2.4.2 of protocol states only 3 months but 2.2 states 3 and 6 months - will clarify with study team}

  6. Late toxicity

    Defined as the proportion of patients with available toxicity data and the proportion of all treated patients through cumulative incidence estimates with death treated as a competing risk and censoring for patients lost to follow-up (FU).

    Measured: up to 24 months post definitive treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start27 Apr 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05894083
Sponsor's protocol ID
UMCC 2022.043
Other IDs
HUM00221848
Status last verified
Jan 2026
First submitted
30 May 2023
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery, Chemoradiation and Observation in people with Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loco-regional recurrence free survival (LR-RFS) rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05894083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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