Cardiovascular and interventional radiology · 2023
Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Dijkstra Madelon, Kuiper Babette I, Schulz Hannah H, van der Lei Susan, Puijk Robbert S, Vos Danielle J W, Timmer Florentine E F, Scheffer Hester J, Buffart Tineke E, van den Tol M Petrousjka, Lissenberg-Witte Birgit I, Swijnenburg Rutger-Jan, Versteeg Kathelijn S, Meijerink Martijn R, COLLISION Trial Group
Аннотация
PURPOSE: The objective of the COLLISION RELAPSE trial is to prove or disprove superiority of neoadjuvant systemic therapy followed by repeat local treatment (either thermal ablation and/or surgical resection), compared to repeat local treatment alone, in patients with at least one recurrent locally treatable CRLM within one year and no extrahepatic disease.
METHODS: A total of 360 patients will be included in this phase III, multicentre randomized controlled trial. The primary endpoint is overall survival. Secondary endpoints are distant progression-free survival, local tumour progression-free survival analysed per patient and per tumour, systemic therapy-related toxicity, procedural morbidity and mortality, length of hospital stay, pain assessment and quality of life, cost-effectiveness ratio and quality-adjusted life years.
DISCUSSION: If the addition of neoadjuvant systemic therapy to repeat local treatment of CRLM proves to be superior compared to repeat local treatment alone, this may lead to a prolonged life expectancy and increased disease-free survival at the cost of possible systemic therapy-related side effects.
LEVEL OF EVIDENCE: Level 1, phase III randomized controlled trial.
TRIAL REGISTRATION: NCT05861505. May 17, 2023.
METHODS: A total of 360 patients will be included in this phase III, multicentre randomized controlled trial. The primary endpoint is overall survival. Secondary endpoints are distant progression-free survival, local tumour progression-free survival analysed per patient and per tumour, systemic therapy-related toxicity, procedural morbidity and mortality, length of hospital stay, pain assessment and quality of life, cost-effectiveness ratio and quality-adjusted life years.
DISCUSSION: If the addition of neoadjuvant systemic therapy to repeat local treatment of CRLM proves to be superior compared to repeat local treatment alone, this may lead to a prolonged life expectancy and increased disease-free survival at the cost of possible systemic therapy-related side effects.
LEVEL OF EVIDENCE: Level 1, phase III randomized controlled trial.
TRIAL REGISTRATION: NCT05861505. May 17, 2023.