Study Comparing Single-Fraction SBRT and Standard Radiation Therapy for Metastatic Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04068649

Provider View

This clinical trial is exploring whether a single, high-precision dose of radiation (SBRT) is as effective as standard radiation therapy for patients with cancer that has spread to other parts of the body. The study aims to see if SBRT can reduce pain and improve quality of life with fewer treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of single-fraction stereotactic body radiation therapy (SBRT) with standard radiation therapy in treating patients whose cancer has spread to other areas of the body (metastatic cancer). SBRT uses advanced technology to deliver a precise, high-dose of radiation to tumors, potentially reducing the number of treatments needed and minimizing damage to healthy tissue.

Description

The study has several goals:

  • Primary Goal: To evaluate how well patients report pain relief and quality of life after receiving either single-fraction SBRT or standard palliative radiation therapy.

  • Secondary Goal: To compare the overall survival rates of patients receiving single-fraction SBRT versus standard radiation therapy.

  • Exploratory Goals: To investigate changes in immune markers, assess any side effects from radiation treatment, monitor changes in frailty and cognitive function over time, evaluate the impact of treatment timing on outcomes, and explore the usefulness of a pain assessment tool.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will receive 1, 3-5, 5-6, or 10 sessions of standard palliative radiation therapy, as determined by their doctor.

  • Group 2: Patients will receive a single session of SBRT.

After completing the treatment, patients may have follow-up visits at 5 and 12 weeks to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer.
  • Have evidence that the cancer has spread to other parts of the body.
  • Have a cancer site causing symptoms or likely to cause symptoms soon, where radiation can help.
  • Agree to use effective birth control if of child-bearing potential.
  • If having another type of cancer, it must be under control or confirmed as metastatic.
  • Be willing to participate in study activities, including surveys and assessments.
  • Understand the study is experimental and sign a consent form before starting.

Exclusion Criteria

  • Have had radiation therapy to the same area planned for treatment in this study.
  • Have known cancer spread to the brain.
  • Are pregnant or breastfeeding.
  • Cannot accurately report their pain medication use.
  • Need or plan to have surgery on the area planned for radiation.
  • Have severe health issues like recent heart problems, infections needing IV antibiotics, or serious lung conditions.
  • Are unable or unwilling to follow study requirements.
  • Are unable to give consent or are under 18 years old.
  • Are pregnant or in prison.

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