RecruitingPhase 2NCT06702033

The Minimalist Trial-2

Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial-2 (MINT-2)"


Sponsor

Washington University School of Medicine

Enrollment

142 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a less intensive treatment approach (fewer lymph nodes removed and potentially less radiation) for people with HPV-related throat cancer (oropharyngeal squamous cell carcinoma) who are having surgery through the mouth, to see if reducing treatment is just as effective with fewer side effects. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HPV-positive throat cancer at early-to-intermediate clinical stages (not T1N0 or T2N0) - You are scheduled for surgery through the mouth to remove the tumor - You are also having selective neck surgery - Your organ function (kidneys, blood) is adequate **You may NOT be eligible if...** - Your cancer is the very earliest stage (T1N0 or T2N0) - You have previously had radiation to the head and neck area - You need a free-flap tissue reconstruction after your surgery - You have advanced liver disease (cirrhosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONRadiation therapy

IMRT or IMPT

DRUGCisplatin

Dose of 100 mg/m\^2 IVPB over 60 minutes

PROCEDURESurgery

Standard of care


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06702033