TY - JOUR
T1 - Recurrent Colorectal Liver Metastases
T2 - Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial
AU - Dijkstra, Madelon
AU - Kuiper, Babette I.
AU - Schulz, Hannah H.
AU - van der Lei, Susan
AU - Puijk, Robbert S.
AU - Vos, Danielle J. W.
AU - Timmer, Florentine E. F.
AU - Scheffer, Hester J.
AU - Buffart, Tineke E.
AU - van den Tol, M. Petrousjka
AU - Lissenberg-Witte, Birgit I.
AU - Swijnenburg, Rutger-Jan
AU - Versteeg, Kathelijn S.
AU - Meijerink, Martijn R.
N1 - Funding Information: The COLLISION RELAPSE trial is a phase III, multicentre randomized controlled trial initiated by the Amsterdam University Medical Centers (Amsterdam UMC), location VUmc in Amsterdam, the Netherlands. This study is endorsed by the Dutch Colorectal Cancer Group (DCCG) and by the Dutch Colorectal Cancer Foundation. Patients will be recruited in at least four centres in the Netherlands: Amsterdam UMC (location VUmc); Noordwest Ziekenhuisgroep Alkmaar; Leiden University Medical Center and Máxima Medisch Centrum, Veldhoven and Eindhoven. Additional Dutch and Belgian high volume liver centres are expected to contribute pending local approvals. Publisher Copyright: © 2023, The Author(s).
PY - 2023
Y1 - 2023
N2 - 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. Graphical Abstract: [Figure not available: see fulltext.].
AB - 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. Graphical Abstract: [Figure not available: see fulltext.].
KW - Colorectal cancer
KW - Colorectal liver metastases (CRLM)
KW - Neoadjuvant systemic therapy
KW - Randomized controlled trial (RCT)
KW - Surgery
KW - Thermal ablation
UR - http://www.scopus.com/inward/record.url?scp=85176115347&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00270-023-03602-y
DO - https://doi.org/10.1007/s00270-023-03602-y
M3 - Article
C2 - 37943351
SN - 0174-1551
JO - Cardiovascular and interventional radiology
JF - Cardiovascular and interventional radiology
ER -