The Minimalist Trial-2: Study on Reducing Treatment Side Effects in HPV-Related Oropharyngeal Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT06702033

Provider View

This study is exploring ways to reduce the side effects of treatment for HPV-related oropharyngeal cancer while keeping the cancer from coming back. It involves surgery followed by different levels of radiation and chemotherapy based on the cancer's risk level.

Patient Parameters

Program Overview

Oropharyngeal squamous cell carcinoma (OPSCC) is a type of head and neck cancer often linked to the human papillomavirus (HPV). While current treatments are effective, they can cause significant side effects. This study aims to find out if reducing the intensity of treatment can still effectively manage the cancer with fewer side effects. Patients will have surgery to remove the tumor and affected neck nodes. Depending on the cancer's risk level, they will receive different levels of radiation and chemotherapy. Those with high-risk cancer will receive the most treatment, while those with intermediate risk will be randomly assigned to one of three treatment levels. Patients with the highest and lowest risk will not continue in the trial after surgery and will follow standard treatment options.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HPV-related oropharyngeal cancer at stages I-II, or HPV-related neck node with unknown primary, but not T1N0M0 or T2N0M0 stages.
  • Plan to have the primary tumor removed through the mouth using specific surgical methods.
  • Plan to have selective neck dissection on one or both sides.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate kidney and blood cell function as shown by specific medical tests.
  • At least 18 years old.
  • Agree to use effective birth control during the study.
  • Able to understand and willing to sign a consent form, or have a representative do so.

Exclusion Criteria

  • Have T1N0M0 or T2N0M0 stage cancer.
  • Have had radiation therapy for head and neck cancer before.
  • Plan to have a free-flap reconstruction surgery.
  • Have severe liver disease (Child-Pugh Score B or C).
  • Have had another invasive cancer diagnosed within the last 2 years, unless it was low-risk and treated successfully.
  • Are taking other experimental drugs.
  • Have serious uncontrolled illnesses or psychiatric conditions that would interfere with the study.
  • Are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test before joining the study.

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110Saint LouisMissouri

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