The Minimalist Trial-2

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Radiation therapy (Radiation): IMRT or IMPT
• Cisplatin (Drug): Dose of 100 mg/m^2 IVPB over 60 minutes
• Surgery (Procedure): Standard of care

Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan
• radiation: Part of the study plan

Main goals

• Recurrence rate (At 2 years)

Other goals

• Percent weight loss
• Proportion of patients undergoing PEG tube placement
• Duration of need for an indwelling PEG tube
• Proportion of patients taking narcotic
• Number of participants with adverse events
• Mean change in serum creatinine during radiation therapy
• Progression-free survival (PFS)
• Overall survival (OS)

Planned enrollment: 142 (estimated).

• Washington University School of Medicine, St Louis, Missouri
• Sanford Roger Maris Cancer Center, Fargo, North Dakota
• Sanford Cancer Center, Sioux Falls, South Dakota

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06702033

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 23, 2026. Public record; not medical advice.