Post-operative Treatment for HPV-positive Throat Tumors (PATHOS)

Sponsor: Lisette Nixon

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02215265

Provider View

This study is exploring if reducing the intensity of post-surgery treatments can improve swallowing and maintain survival rates in patients with HPV-positive throat cancer. The goal is to tailor treatments based on the cancer's characteristics to achieve the best outcomes.

Patient Parameters

Program Overview

The PATHOS study aims to find out if less intense treatments after surgery can help patients with HPV-positive throat cancer swallow better, without affecting their survival. The study will personalize treatment plans based on the cancer's biology, such as HPV status and other findings, to improve patient outcomes.

Description

The PATHOS study is a large clinical trial involving multiple centers. It is designed to test if reducing the intensity of treatments after surgery can help patients with HPV-positive throat cancer. The study has two phases: Phase II, which has already been completed, and Phase III, which is ongoing and aims to recruit about 1100 patients.

Patients eligible for the study must have a specific type of throat cancer that can be removed through surgery. They will undergo tests to assess their swallowing ability and quality of life before surgery. After surgery, patients will be divided into groups based on the risk of cancer returning:

  • Group A: Patients with low-risk tumors will not receive additional treatment.
  • Group B: Patients with moderate-risk tumors will receive either a standard or reduced dose of radiation therapy.
  • Group C: Patients with high-risk tumors will receive either radiation therapy with chemotherapy or just radiation therapy.

Patients will be monitored for swallowing ability and quality of life at various intervals after treatment. The study will also track any side effects from the treatments. Data will be collected and analyzed to ensure the study's accuracy and reliability.

The study uses an electronic system for data collection and patient registration. Patients will be randomly assigned to treatment groups to ensure balanced treatment allocation. The study's success will be measured by improvements in swallowing and overall survival rates.

An independent committee will review the study data regularly to decide if the study should continue or if any changes are needed. The study will also analyze how different factors, like tumor location and surgery type, affect swallowing outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed or suspected squamous cell carcinoma of the oropharynx.
  • Cancer stage T1-T3, N0-N2b (or T1-T3, N0-N1) according to specific medical guidelines.
  • Decision by a medical team to treat with surgery and neck dissection.
  • Patients must be fit for surgery and additional radiation therapy.
  • Aged 18 or older.
  • Must provide written informed consent.

Exclusion Criteria

  • Known HPV-negative throat cancers.
  • Tumors that cannot be removed through surgery.
  • Advanced nodal disease beyond specific stages.
  • Patients for whom surgery is not the primary treatment.
  • Current smokers with certain cancer stages, even if HPV-positive. Vaping is allowed.
  • Pre-existing conditions affecting swallowing or a history of swallowing issues before cancer.
  • Cancer that has spread to distant parts of the body.
  • History of other cancers in the last 5 years, except for certain skin or cervical cancers.
  • Pregnant or breastfeeding women, and women not using contraception during the trial.

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