In clinical trials, a common eligibility requirement is “measurable disease.” This is because researchers are often required to measure the size of tumors to evaluate whether a treatment is working. However, some tumors metastasize to sites where they cannot be easily measured, such as the brain, leptomeninges (the membranes surrounding the brain), bones, or gastrointestinal organs. The criteria for measuring solid tumors are called Response Evaluation Criteria in Solid Tumors (RECIST), and measurable disease is one of the RECIST criteria. If you do not have “measurable disease” at any site, you may be excluded from some treatment trials.
Efforts are underway to move beyond the restrictions of measurable disease to allow more people to enroll in clinical trials. A recent effort called “Response Assessment in Neuro-Oncology” (RANO) is trying to improve and standardize how treatment of brain and leptomeningeal metastases is assessed in clinical trials. The patient voice is also important when determining how well a treatment is working.
Click the links below to learn more about these efforts. On Metastatic Trial Search, you can specify whether you have measurable or non-measurable disease to find trials that match your specific situation.
Criteria for Brain and Leptomeningeal Metastases
- Response Evaluation Criteria in Solid Tumors: Response Assessment in People with Brain Metastases
- Journal Article: A RANO Proposal for Response Criteria for Leptomeningeal Metastases
Criteria for Bone-Only Metastases
- Journal Article (Scroll to “Introduction”): Characterization of Bone-Only Metastasis
The Patient Voice in Measuring Clinical Trial Success
- Journal Article (Scroll to “Patient and/or Advocate Perspective”): Clinical Trials in Metastatic Breast Cancer: Design Features and Endpoints That Matter
Last Modified on September 30, 2022
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