Clinical Research Operations

Measuring Solid Tumors Using Response Evaluation Criteria in Solid Tumors (RECIST)

Purpose: To identify the process to be followed when using RECIST criteria to evaluate solid tumors.

STEP 1: Confirm RECIST Criteria Are Used in the Protocol to Determine Solid Tumor Response

1. If RECIST criteria has been selected as the method to evaluate solid tumors response, it should be specified in the protocol including the RECIST version (i.e., 1.0 or 1.1) and the evaluation timeline.
2. If RECIST is not used to determine solid tumor response, the protocol should detail how tumor response will be evaluated including response definitions.

STEP 2: Using RECIST When Documenting Measurements of Target and Non-Target Lesions

1. A consistent physician-of-record or designee should identify and measure target lesions and non-target lesions at baseline and at the protocol-specific evaluation timeline.
   • For RECIST 1.0, refer to the NCI Cancer Imaging Program’s guidelines: http://www3.cancer.gov/bip/RECIST.htm (page not found)
   • For RECIST 1.1, refer to the European Journal of Cancer (EJC). The guidelines are found at:
     http://www.eortc.be/Recist/documents/RECISTGuidelines.pdf.
2. All target and non-target lesions should be documented in CRIS on the Tumor Measurement/RECIST flow sheet at the time of initial measurement.
   • A second flow sheet entry may be entered for the initial scan dates if a more formal review is conducted with the radiologist and oncologist.
     • Access CRIS.
     • Locate specific patient.
     • Once in an individual patient’s record, select the tab for flow sheets.
     • Using the left-side filter function, search for ‘tumor measurement’.
     • Select the version of RECIST that is appropriate for the protocol.
     • Enter the information for the time point assessment including, but not limited to: lesion number, lesion site/description, lesion type (target/non-target), modality of measurement, longest diameter, target lesion response, non-target lesion response, overall response.
3. If protocol uses C3D, abstract/record tumor measurement data from CRIS documentation.