The Minimalist Trial-2 for HPV-Related Oropharynx Squamous Cell Carcinoma

This study, called The Minimalist Trial-2, is looking at new ways to treat HPV-related oropharynx squamous cell carcinoma (OPSCC), a type of head and neck cancer. The goal is to find treatments that are just as effective but cause fewer side effects. Researchers are studying different combinations of radiation therapy (IMRT or IMPT), the chemotherapy drug cisplatin, and surgery. To join, you must be at least 18 years old and have HPV-related OPSCC that is clinical stage I-II, or HPV-related neck node with an unknown primary tumor. Your cancer must be confirmed as HPV-related by specific tests. The study will measure how many patients have their cancer return within two years. The current status of this study is unclear.

Study design: This is an interventional study planning to enroll 142 participants. The specific phase of the study is not mentioned.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study will follow participants to measure the recurrence rate of cancer at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The Minimalist Trial-2

Recruiting

PHASE2Ages 18+InterventionalTreatment

Washington University School of Medicine

~142 participants

Updated 2026-07-24 on ClinicalTrials.gov

What's tested:Radiation therapyCisplatinSurgery

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Recurrence rate

Measured over At 2 years

Conditions

HPV-Related Oropharynx Squamous Cell Carcinoma

Where it's being run

3 sites across 3 states

Missouri1

North Dakota1

South Dakota1

Study leadership

Douglas Adkins, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Douglas Adkins, M.D.

[email protected]

314-747-8475

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.

Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).

Planned unilateral or contralateral selective neck dissection.

ECOG PS 0-2.

Adequate organ and marrow function defined as:

Creatinine clearance ≥ 50 mL/min.

ANC ≥ 1.0 K/cumm.

Platelet count ≥100 K/cumm.

At least 18 years of age.

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion

Clinical T1N0M0 or T2N0M0 disease.

Prior radiation therapy for HNSCC.

Planned free-flap reconstruction of the resected primary site.

Cirrhosis with Child-Pugh Score B or C.

History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS \> 90%) that were treated with curative-intent therapy.

Receiving any other investigational agents.

Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.

What this trial measures

Recurrence rateAt 2 years

Trialytics