Handbook of Targeted Cancer Therapy and Immunotherapy

Table 10.1: Selected prospective randomized clinical trials of ctDNA to inform clinical decision-making

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Clinical Trial

Description

Primary Endpoints and Results

COBRA (NCT04068103) Phase II/III colon cancer

• Stage IIA colon cancer without high-risk features a 1:1 to SOC observation (Arm A) or prospec tive testing for ctDNA (Arm B). • Arm B: if detectable ctDNA post-op, then 6 months adjuvant chemotherapy • Stage II CRC randomized 1:1 for treatment based on ctDNA result (Arm A) vs. SOC per physician (Arm B). • Arm A: if detectable ctDNA post-op, then 5-fluorouracil-based chemo • Stage III colon cancer random ized 1:1 per post-op ctDNA (Arm B) or SOC (Arm A). Stratified for low (T1-3N1) and high (T4 or N2) risk. • Arm B: ctDNA negative managed with deescalation adjuvant treat ment and ctDNA positive with escalation adjuvant strategy.

• ctDNA clearance with adjuvant therapy • RFS for Arm B Results: Study ongoing

DYNAMIC II (ACTRN12615000381583)

• Does ctDNA-based adjuvant therapy decision affect number of patients who receive chemo therapy, and RFS? Results: Study ongoing

DYNAMIC III (ACTRN12617001566325) Phase II/III colon cancer (Australia)

• Evaluate impact of deescalation/ escalation ctDNA-based strategies. Results: Study ongoing

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