Actively Recruiting
The Minimalist Trial-2
Led by Washington University School of Medicine · Updated on 2026-05-13
142
Participants Needed
1
Research Sites
431 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Joseph Sanchez Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (\>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate. In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to: * Arm 1 (de-POACRT-42 Gy) * Arm 2A (de-POART-42 Gy) * Arm 2B (de-POART-37.8 Gy) * Arm 2C (de-POACRT-30 Gy). All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.
CONDITIONS
Official Title
The Minimalist Trial-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HPV-related clinical stages I-II OPSCC or HPV-related neck node with unknown primary, excluding clinical T1N0M0 and T2N0M0 disease
- Planned resection of the primary tumor by a transoral approach (TORS, TLM, or conventional surgery)
- Planned unilateral or contralateral selective neck dissection
- ECOG performance status of 0-2
- Adequate organ and marrow function with creatinine clearance ≥ 50 mL/min, ANC ≥ 1.0 K/cumm, and platelet count ≥ 100 K/cumm
- At least 18 years of age
- Women of childbearing potential and men must agree to use contraception during study participation
- Ability to understand and sign informed consent (or legally authorized representative)
You will not qualify if you...
- Clinical T1N0M0 or T2N0M0 disease
- Prior radiation therapy for head and neck squamous cell carcinoma
- Planned free-flap reconstruction of the resected primary site
- Cirrhosis with Child-Pugh Score B or C
- History of invasive malignancy diagnosed within 2 years before enrollment, except low-risk malignancies treated with curative intent
- Receiving other investigational agents
- Uncontrolled serious inter-current illness or serious psychiatric illness/social situations limiting compliance
- Pregnant or breastfeeding; negative serum pregnancy test required for women of childbearing potential
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
D
Douglas Adkins, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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