Study on Stereotactic Body Radiation Therapy for Bone Cancer Spread

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02880319

Provider View

This clinical trial is exploring a precise form of radiation therapy called stereotactic body radiation therapy (SBRT) to treat cancer that has spread to the bones, including the spine.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a specialized radiation treatment called stereotactic body radiation therapy (SBRT) for cancer that has spread to the bones. SBRT is an advanced technique that delivers high doses of radiation directly to the tumor while minimizing exposure to surrounding healthy tissues. This study aims to see if SBRT can better control bone cancer spread and reduce symptoms like pain, compared to standard radiation therapy.

Description

This Phase II clinical trial is investigating the use of stereotactic body radiation therapy (SBRT) for treating bone metastases, which are cancerous growths that have spread to the bones. SBRT is a precise form of radiation that targets tumors with high doses while sparing nearby healthy tissue. This study will evaluate how well SBRT controls cancer in the bones and whether it causes fewer side effects than traditional radiation therapy.

SBRT has been successfully used in treating cancers in the lungs and liver, showing good results in controlling tumors and preventing them from returning. In this study, researchers want to see if SBRT can effectively manage bone metastases and alleviate symptoms like pain. While SBRT aims to stop the growth of cancer cells in bone metastases, it is not intended to cure the cancer. The main goal is to assess how well SBRT controls the disease in the bones and manages symptoms without increasing side effects.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Good overall health with an ECOG performance status of 0 to 2
  • Diagnosed with a solid tumor that has spread to the bones (spine or other bones)
  • Bone metastases must be 6 cm or smaller and visible on a CT or MRI scan; spine metastases must involve 3 or fewer connected vertebrae
  • No other active cancer in the past 2 years, except for certain skin cancers or cervical cancer in situ
  • Able to understand and sign a consent form
  • Surgery on the bone lesion is allowed if size criteria are met
  • Not pregnant or breastfeeding

Cohort 1: Oligometastatic state

  • 3 or fewer active cancer sites, including the primary site
  • Life expectancy of more than 3 months
  • Other metastatic sites have been treated or are planned for treatment

Cohort 2: Re-irradiation

  • Previous radiation in the current area needing treatment
  • Life expectancy of more than 3 months

Exclusion Criteria

  • SBRT target larger than 6 cm in diameter
  • Blood cancers like lymphoma or multiple myeloma
  • Previous radiation dose higher than 100 Gy2
  • Tumor less than 2 mm from the spinal cord
  • Need for ongoing systemic therapies during SBRT (hormonal therapies allowed)
  • Unable to lie still for treatment despite medication
  • Non-English speakers due to unvalidated questionnaires
  • Unable to describe symptoms, affecting questionnaire completion
  • Pregnant women due to potential risks of radiation
  • History of another cancer unless disease-free for 2 years or low risk of recurrence, except for certain skin or cervical cancers

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02115BostonMassachusetts

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