Study on Radiation Therapy for Patients with Advanced Non-Small Cell Lung Cancer at High Risk of Worsening Symptoms in the Chest

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06262321

Provider View

This clinical trial is exploring whether adding radiation therapy to the chest can help manage symptoms in patients with advanced non-small cell lung cancer (NSCLC) that is at high risk of worsening. The study involves using radiation alongside standard treatments like chemotherapy or immunotherapy.

Patient Parameters

Program Overview

The purpose of this study is to see if radiation therapy directed at high-risk areas in the chest can help control symptoms in patients with advanced non-small cell lung cancer (NSCLC). Patients will receive radiation in addition to their usual treatment, which may include chemotherapy or immunotherapy. The study focuses on areas in the chest that are more likely to cause problems due to the size or location of the cancer.

Description

This study is a Phase II trial for patients with stage IV non-small cell lung cancer (NSCLC). Participants will receive standard treatments like chemotherapy or immunotherapy, along with radiation therapy aimed at high-risk areas in the chest, such as the main tumor, lymph nodes, and other metastases. Radiation to other areas outside the chest is allowed if needed. The radiation doses will follow established guidelines, and there is no plan to increase the dose beyond what is typically used for symptom relief in NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) without specific genetic mutations.
  • Have stage IV cancer or a recurrence of earlier-stage cancer that has spread, without previous chest radiation.
  • Have lung or lymph node tumors in the chest that can be treated with radiation.
  • Must have one or more high-risk features, such as a large lung tumor (5 cm or more) or tumors near critical areas like the bronchial tubes, esophagus, or heart.
  • Can have had previous systemic therapy and must join the study within 6 months of starting it.
  • Can continue systemic therapy after radiation.
  • Previous palliative surgery is allowed.
  • Cannot have chemotherapy at the same time as radiation, but immunotherapy is allowed.
  • Can have had radiation to other areas outside the chest for symptom relief.
  • Can have radiation for painful bone metastases in the chest at the same time as the study treatment.

Exclusion Criteria

  • Previous radiation therapy to the chest.
  • Have active autoimmune diseases like lupus or Sjogren's.
  • Have severe symptoms from lung cancer that require immediate radiation for reasons other than bone pain, such as severe breathing problems or spinal cord compression.
  • Have a poor overall health status (ECOG score of 3-4).
  • Have brain metastases that cannot be treated with immunotherapy, surgery, or targeted radiation.
  • Have a malignant pleural effusion with visible pleural disease, unless it can be managed with fluid drainage and there is no visible pleural disease on scans.

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