Feasibility of Real‐Time Central Risk Assignment for Children's Oncology Group Pediatric Renal Tumor Trials

BACKGROUND: The Children's Oncology Group (COG) AREN03B2 Renal Tumor Biology and Classification Study undertook real-time central reviews to enable accurate risk stratification for enrollment on therapeutic trials. The present study assessed the feasibility of the central review process on timely therapeutic protocol assignment. PROCEDURE: COG Renal Tumor Committee members performed real-time central radiology review to assess lung metastasis and bilateral renal lesions, pathology review for histologic diagnosis and pathological stage, and surgery review to assess surgical approach and staging. An Initial Risk Assignment (IRA) was made to determine eligibility for therapeutic studies based on these reviews. An IRA within 14 days of initial procedure was required to enroll on therapeutic studies. RESULTS: During the first-generation COG therapeutic studies, AREN03B2 enrolled 2358 patients who received a study-qualifying IRA. For the 2008 patients with unilateral tumors, median time from initial procedure to IRA was 12 days (IQR: 9.6-15.2), with 73.8% of patients receiving IRAs within 14 days from initial procedure. Median time spent in various steps of review (in sequence and/or parallel) was: 3.0 days from initial procedure to enrollment, 1.1 days from imaging submission to central imaging review, 5.7 days from initial procedure to specimen submission to the biopathology center, 4.0 days from specimen submission to pathology review, 0.7 days from the imaging or pathology review to surgical review, and 0.1 days from surgical review completion to IRA completion. CONCLUSIONS: Real-time central review on AREN03B2 was feasible and enabled on-time enrollment onto therapeutic trials in nearly 75% of protocol-eligible patients. GOV IDENTIFIER: NCT00898365 Aren03b2.