Study on Transoral Surgery and Reduced Radiation Therapy for Treatable HPV-Positive Oropharyngeal Cancer

Sponsor: Heath Skinner

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05388773

Provider View

This clinical trial is exploring a treatment plan for patients with HPV-positive oropharyngeal cancer that can be surgically removed. After surgery, patients will be categorized into risk groups to determine if they need additional treatment with radiation or chemotherapy.

Patient Parameters

Program Overview

This study is for patients with HPV-positive oropharyngeal cancer that can be removed through surgery. After the surgery, patients will be placed into one of three groups based on their risk level. Low-risk patients will not need further treatment. Intermediate-risk patients will receive a type of radiation therapy called Intensity Modulated Radiotherapy (IMRT). High-risk patients will receive both IMRT and chemotherapy. The study will follow patients for up to five years to monitor their health and treatment outcomes.

Description

This phase II trial is designed to carefully reduce the amount of radiation therapy needed after surgery for patients with treatable oropharyngeal cancer that is HPV-positive. Patients will be divided into three groups based on their risk level after surgery: low, intermediate, and high risk.

  • Low-risk patients will only need observation after surgery.
  • Intermediate-risk patients will receive 30 Gy of radiation in 15 sessions using IMRT.
  • High-risk patients will receive 50 Gy of radiation in 25 sessions, with one day a week having two treatments, along with chemotherapy using cisplatin for five weeks. If cisplatin is not suitable, carboplatin will be used instead.

The study aims to find the best balance of treatment to effectively manage the cancer while minimizing side effects. Patients will be monitored for up to five years to assess the long-term outcomes of these treatment strategies.

Eligibility Criteria

Inclusion Criteria

  • Good overall health with a performance status score of 0 or 1.
  • Newly diagnosed with a type of throat cancer that can be surgically removed.
  • Eligible for surgery with no signs of cancer spread to distant parts of the body.
  • Cancer must be HPV-positive, confirmed by specific lab tests.
  • No previous radiation treatment above the collarbone.
  • If previously treated for another cancer, must be cancer-free for at least two years, except for certain skin cancers or cervical cancer.
  • If there are heart or brain health concerns, must be evaluated by a specialist.
  • Must have acceptable kidney and liver function as determined by recent tests.

Exclusion Criteria

  • No extensive or fixed lymph node involvement as seen on pre-surgery scans.
  • Women must not be pregnant or breastfeeding due to potential risks from chemotherapy.
  • No other illnesses that could interfere with treatment or surgery.
  • No uncontrolled diabetes, infections, or high blood pressure within the last 30 days.

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