Unresectable Intermediate-Size (3–5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial

van der Lei, Susan; Dijkstra, Madelon; Nieuwenhuizen, Sanne; Schulz, Hannah; Vos, Danielle; Versteeg, Kathelijn; Buffart, Tineke; Swijnenburg, Rutger-Jan; de Vries, Jan; Bruynzeel, Anna; van den Tol, M.; Scheffer, Hester; Puijk, Robbert; Haasbeek, Cornelis; Meijerink, Martijn; Geboers, Bart; Timmer, Floor; Verheul, Henk; Nielsen, Karin; Van der Meijs, Bram; Van Grieken, Nicole; Van Delden, Otto; Van Gulik, Thomas; Besselink, Mark; Tanis, Pieter; Van Lienden, Krijn; Burgmans, Mark; Van Erkel, Arian; Hartgrink, Henk; Van Rijswijk, Carla; Mieog, Sven; Sietses, Colin; Van Heek, Tjarda; Diederik, Arjen; Spaargaren, Gert-Jan; Groot, Gerie; Vink, Ted; Manusama, Eric; EKER, Hasan; Dol, Johan; Kappers, Ingrid; Van der Leij, Christiaan; Brans, Rutger; Coolsen, Mariëlle; De Jong, Kees; Van Dam, Ronald; Kruimer, Han; Van Baardewijk, Laurens; Leclercq, Wouter; Futterer, Jurgen; Van den Boezem, Peter; Stommel, Martijn; De Wilt, Hans; Jenniskens, Sjoerd; Arntz, Mark; Janssen, Jan; Torrenga, Hans; Ruiter, Simeon; Nijkamp, Maarten; Kater, Matthijs; De Jong, Koert; Serafino, GianPiero; Draaisma, Werner; Van Geel, Anne; Schreurs, Hermien; Smits, Maarten; Hagendoorn, Jeroen; Molenaar, Quintus; Bruijnen, Rutger; Prevoo, Warner; De Cobelli, Francesco; Aldrighetti, Luca; Ratti, Francesca; Marra, Paolo; Corte, Angelo; Chapelle, Thiery; Peeters, Marc

doi:10.1007/s00270-023-03498-8

Unresectable Intermediate-Size (3–5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial

van der Lei S., Dijkstra M., Nieuwenhuizen S., Schulz H. H., Vos D. J. W., Versteeg K. S., ...Daha Fazla

CardioVascular and Interventional Radiology, cilt.46, sa.8, ss.1076-1085, 2023 (SCI-Expanded, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 46 Sayı: 8
Basım Tarihi: 2023
Doi Numarası: 10.1007/s00270-023-03498-8
Dergi Adı: CardioVascular and Interventional Radiology
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CINAHL, EMBASE
Sayfa Sayıları: ss.1076-1085
Anahtar Kelimeler: Colorectal cancer, Colorectal liver metastases (CRLM), Liver metastases, Thermal ablation, Microwave ablation (MWA), Radiotherapy, Stereotactic body radiotherapy (SBRT), Randomized controlled trial (RCT)
Sağlık Bilimleri Üniversitesi Adresli: Evet

Özet

Background: Although microwave ablation (MWA) has a low complication rate and good efficacy for small-size (≤ 3 cm) colorectal liver metastases (CRLM), local control decreases with increasing size. Stereotactic body radiotherapy (SBRT) is gaining interest as a potential means to treat intermediate-size CRLM and might be less susceptible to increasing volume. The objective of this study is to compare the efficacy of MWA to SBRT in patients with unresectable, intermediate-size (3–5 cm) CRLM. Methods: In this two-arm, multicentre phase II/ III randomized controlled trial, 68 patients with 1–3 unresectable, intermediate-size CRLM suitable for both MWA and SBRT, will be included. Patients will be treated with MWA or SBRT as randomised. The Primary endpoint is local tumour progression-free survival (LTPFS) at 1 year (intention-to-treat analysis). Main secondary endpoints are overall survival, overall and distant progression-free survival (DPFS), local control (LC) and procedural morbidity and mortality and assessment of pain and quality of life. Discussion: Current guidelines lack clear recommendations for the local treatment of liver only intermediate-size, unresectable CRLM and studies comparing curative intent SBRT and thermal ablation are scarce. Although safety and feasibility to eradicate tumours ≤ 5 cm have been established, both techniques suffer from lower LTPFS and LC rates for larger-size tumours. For the treatment of unresectable intermediate-size CRLM clinical equipoise has been reached. We have designed a two-armed phase II/ III randomized controlled trial directly comparing SBRT to MWA for unresectable CRLM 3–5 cm. Level of Evidence : Level 1, phase II/ III Randomized controlled trial. Trial Registration: NCT04081168, September 9th 2019. Graphical Abstract: [Figure not available: see fulltext.]