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.
Colorectal cancer
Colorectal liver metastases (CRLM)
Neoadjuvant systemic therapy
Randomized controlled trial (RCT)
Surgery
Thermal ablation
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
09 Nov 2023
09 Nov 2023
Historique:
received:
15
07
2023
accepted:
17
10
2023
medline:
9
11
2023
pubmed:
9
11
2023
entrez:
9
11
2023
Statut:
aheadofprint
Résumé
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. 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. 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 1, phase III randomized controlled trial. NCT05861505. May 17, 2023.
Identifiants
pubmed: 37943351
doi: 10.1007/s00270-023-03602-y
pii: 10.1007/s00270-023-03602-y
doi:
Banques de données
ClinicalTrials.gov
['NCT05861505']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
Références
WHO. Estimated age-standardized incidence rates (World) in 2020, all cancers, both sexes, all ages 2020. http://gco.iarc.fr/today/online-analysis-map .
Engstrand J, Nilsson H, Stromberg C, Jonas E, Freedman J. Colorectal cancer liver metastases—a population-based study on incidence, management and survival. BMC Cancer. 2018;18(1):78.
pubmed: 29334918
pmcid: 5769309
Meijerink MR, Puijk RS, van Tilborg A, Henningsen KH, Fernandez LG, Neyt M, et al. Radiofrequency and microwave ablation compared to systemic chemotherapy and to partial hepatectomy in the treatment of colorectal liver metastases: a systematic review and meta-analysis. Cardiovasc Intervent Radiol. 2018;41(8):1189–204.
pubmed: 29666906
pmcid: 6021475
Scheele J, Stangl R, Altendorf-Hofmann A. Hepatic metastases from colorectal carcinoma: impact of surgical resection on the natural history. Br J Surg. 1990;77(11):1241–6.
pubmed: 2253003
Stangl R, Altendorf-Hofmann A, Charnley RM, Scheele J. Factors influencing the natural history of colorectal liver metastases. Lancet. 1994;343(8910):1405–10.
pubmed: 7515134
Yang Q, Liao F, Huang Y, Jiang C, Liu S, He W, et al. Longterm effects of palliative local treatment of incurable metastatic lesions in colorectal cancer patients. Oncotarget. 2016;7(15):21034–45.
pubmed: 26992234
pmcid: 4991510
Wagner JS, Adson MA, Van Heerden JA, Adson MH, Ilstrup DM. The natural history of hepatic metastases from colorectal cancer. A comparison with resective treatment. Ann Surg. 1984;199(5):502–8.
pubmed: 6721600
pmcid: 1353475
Gleisner AL, Choti MA, Assumpcao L, Nathan H, Schulick RD, Pawlik TM. Colorectal liver metastases: recurrence and survival following hepatic resection, radiofrequency ablation, and combined resection-radiofrequency ablation. Arch Surg. 2008;143(12):1204–12.
pubmed: 19075173
Abdalla EK, Vauthey JN, Ellis LM, Ellis V, Pollock R, Broglio KR, et al. Recurrence and outcomes following hepatic resection, radiofrequency ablation, and combined resection/ablation for colorectal liver metastases. Ann Surg. 2004;239(6):818–25 (discussion 25–7).
pubmed: 15166961
pmcid: 1356290
Saiura A, Yamamoto J, Hasegawa K, Koga R, Sakamoto Y, Hata S, et al. Liver resection for multiple colorectal liver metastases with surgery up-front approach: bi-institutional analysis of 736 consecutive cases. World J Surg. 2012;36(9):2171–8.
pubmed: 22547015
Vigano L, Ferrero A, Lo Tesoriere R, Capussotti L. Liver surgery for colorectal metastases: results after 10 years of follow-up. Long-term survivors, late recurrences, and prognostic role of morbidity. Ann Surg Oncol. 2008;15(9):2458–64.
pubmed: 18463927
National Institute for Health and Care Excellence (N.I.C.E.). Treatment for metastatic colorectal cancer in the liver amenable to treatment with curative intent: Colorectal cancer (update): evidence review D2a. 2020. https://www.nice.org.uk/guidance/ng151/evidence/d2a-treatment-for-metastatic-colorectal-cancer-in-the-liver-amenable-to-treatment-with-curative-intent-pdf-253058083672 .
Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2019.
Integraal Kankercentrum Nederland (I.K.N.L.) Guideline Colorectaal Carcinoom. 2019. https://www.oncoline.nl/colorectaalcarcinoom .
Viganò L, Pedicini V, Comito T, Carnaghi C, Costa G, Poretti D, et al. Aggressive and multidisciplinary local approach to iterative recurrences of colorectal liver metastases. World J Surg. 2018;42(8):2651–9.
pubmed: 29423737
Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10–32.
pubmed: 36307056
Petrowsky H, Gonen M, Jarnagin W, Lorenz M, DeMatteo R, Heinrich S, et al. Second liver resections are safe and effective treatment for recurrent hepatic metastases from colorectal cancer: a bi-institutional analysis. Ann Surg. 2002;235(6):863–71.
pubmed: 12035044
pmcid: 1422517
Adam R, Bismuth H, Castaing D, Waechter F, Navarro F, Abascal A, et al. Repeat hepatectomy for colorectal liver metastases. Ann Surg. 1997;225(1):51–60 (discussion'-2').
pubmed: 8998120
pmcid: 1190605
Takamoto T, Hashimoto T, Miyata A, Shimada K, Maruyama Y, Makuuchi M. Repeat hepatectomy after major hepatectomy for colorectal liver metastases. J Gastrointest Surg. 2020;24(2):380–7.
pubmed: 30830515
Dijkstra M, Nieuwenhuizen S, Puijk RS, Timmer FEF, Geboers B, Schouten EAC, et al. Thermal ablation compared to partial hepatectomy for recurrent colorectal liver metastases: an Amsterdam Colorectal Liver Met Registry (AmCORE) Based Study. Cancers. 2021;13(11).
Benoist S, Nordlinger B. The role of preoperative chemotherapy in patients with resectable colorectal liver metastases. Ann Surg Oncol. 2009;16(9):2385–90.
pubmed: 19554377
Heise D, Bayings W, Tuinhof A, Eickhoff R, Kroh A, Ulmer F, et al. Long-term outcome and quality of life after initial and repeat resection of colorectal liver metastasis: a retrospective analysis. Int J Surg. 2017;48:281–5.
pubmed: 29175019
Hellingman T, Kuiper BI, Buffart LM, Meijerink MR, Versteeg KS, Swijnenburg RJ, et al. Survival benefit of repeat local treatment in patients suffering from early recurrence of colorectal cancer liver metastases. Clin Colorectal Cancer. 2021;20(4):e263–72.
pubmed: 34462211
Dijkstra M, Nieuwenhuizen S, Puijk RS, Geboers B, Timmer FEF, Schouten EAC, et al. The role of neoadjuvant chemotherapy in repeat local treatment of recurrent colorectal liver metastases: a systematic review and meta-analysis. Cancers. 2021;13(3):378.
pubmed: 33561088
pmcid: 7864163
Adam R, Pascal G, Azoulay D, Tanaka K, Castaing D, Bismuth H. Liver resection for colorectal metastases: the third hepatectomy. Ann Surg. 2003;238(6):871–83 (discussion 83–4).
pubmed: 14631224
pmcid: 1356169
Ismaili N. Treatment of colorectal liver metastases. World J Surg Oncol. 2011;9:154.
pubmed: 22115124
pmcid: 3251538
NVMO. PASKWIL-criteria aangepast. Med Oncol. 2016;12.
Vigano L, Capussotti L, Lapointe R, Barroso E, Hubert C, Giuliante F, et al. Early recurrence after liver resection for colorectal metastases: risk factors, prognosis, and treatment. A LiverMetSurvey-based study of 6,025 patients. Ann Surg Oncol. 2014;21(4):1276–86.
pubmed: 24346766
Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 2017. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf .
IBM Corp. Released 2019. IBM® SPSS® Statistics for Windows, Version 26.0. Armonk: IBM Corp.
R Core Team. R: a language and environment for statistical computing. R for Windows version 4.0.3. R Foundation for Statistical Computing, Vienna, Austria. 2019.
Specialisten FM. SONCOS Normeringsrapport—multidisciplinaire normering oncologische zorg in Nederlands. 2022.
Brudvik KW, Jones RP, Giuliante F, Shindoh J, Passot G, Chung MH, et al. RAS mutation clinical risk score to predict survival after resection of colorectal liver metastases. Ann Surg. 2019;269(1):120–6.
pubmed: 28549012
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–47.
pubmed: 19097774
de Jong MC, Mayo SC, Pulitano C, Lanella S, Ribero D, Strub J, et al. Repeat curative intent liver surgery is safe and effective for recurrent colorectal liver metastasis: results from an international multi-institutional analysis. J Gastrointest Surg. 2009;13(12):2141–51.
pubmed: 19795176
National Institute for Health and Care Excellence (N.I.C.E.). Radiofrequency ablation for colorectal liver metastases. 2009. https://www.nice.org.uk/guidance/IPG327 .
National Institute for Health and Care Excellence (N.I.C.E.). Microwave ablation for treating liver metastases. 2016. https://www.nice.org.uk/guidance/IPG553 .
Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, et al. Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013;14(12):1208–15.
pubmed: 24120480
Kanemitsu Y, Shimizu Y, Mizusawa J, Inaba Y, Hamaguchi T, Shida D, et al. A randomized phase II/III trial comparing hepatectomy followed by mFOLFOX6 with hepatectomy alone for liver metastasis from colorectal cancer: JCOG0603 study. J Clin Oncol. 2020. 4005.
Nordlinger B, Van Cutsem E, Rougier P, Köhne CH, Ychou M, Sobrero A, et al. Does chemotherapy prior to liver resection increase the potential for cure in patients with metastatic colorectal cancer? A report from the European Colorectal Metastases Treatment Group. Eur J Cancer. 2007;43(14):2037–45.
pubmed: 17766104
Adam R, Delvart V, Pascal G, Valeanu A, Castaing D, Azoulay D, et al. Rescue surgery for unresectable colorectal liver metastases downstaged by chemotherapy: a model to predict long-term survival. Ann Surg. 2004;240(4):644–57 (discussion 57–8).
pubmed: 15383792
pmcid: 1356466
Ayez N, Van Der Stok EP, Grünhagen DJ, Rothbarth J, Van Meerten E, Eggermont AM, Verhoef C. The use of neo-adjuvant chemotherapy in patients with resectable colorectal liver metastases: Clinical risk score as possible discriminator. Eur J Surg Oncol. 2015;41(7):859–67.
pubmed: 25979624
Zhu D, Zhong Y, Wei Y, Ye L, Lin Q, Ren L, et al. Effect of neoadjuvant chemotherapy in patients with resectable colorectal liver metastases. PLoS ONE. 2014;9(1).
Tanaka K, Adam R, Shimada H, Azoulay D, Lévi F, Bismuth H. Role of neoadjuvant chemotherapy in the treatment of multiple colorectal metastases to the liver. Br J Surg. 2003;90(8):963–9.
pubmed: 12905549
Allen PJ, Kemeny N, Jarnagin W, DeMatteo R, Blumgart L, Fong Y. Importance of response to neoadjuvant chemotherapy in patients undergoing resection of synchronous colorectal liver metastases. J Gastrointest Surg. 2003;7(1):109–15 (discussion 16–17).
pubmed: 12559192
Adam R, Wicherts DA, de Haas RJ, Aloia T, Levi F, Paule B, et al. Complete pathologic response after preoperative chemotherapy for colorectal liver metastases: myth or reality? J Clin Oncol. 2008;26(10):1635–41.
pubmed: 18375892
Vigano L, Galvanin J, Poretti D, Del Fabbro D, Gentile D, Pedicini V, et al. Percutaneous ablation of post-surgical solitary early recurrence of colorectal liver metastases is an effective "test-of-time" approach. Updates Surg. 2021.
Wiering B, Oyen WJ, Adang EM, van der Sijp JR, Roumen RM, de Jong KP, et al. Long-term global quality of life in patients treated for colorectal liver metastases. Br J Surg. 2011;98(4):565–71 (discussion 71–2).
pubmed: 21656721
Andreou A, Brouquet A, Abdalla EK, Aloia TA, Curley SA, Vauthey JN. Repeat hepatectomy for recurrent colorectal liver metastases is associated with a high survival rate. HPB (Oxford). 2011;13(11):774–82.
pubmed: 21999590
pmcid: 3238011
Dijkstra M, Nieuwenhuizen S, Puijk RS, Timmer FEF, Geboers B, Schouten EAC, et al. Repeat local treatment of recurrent colorectal liver metastases, the role of neoadjuvant chemotherapy: an Amsterdam Colorectal Liver Met Registry (AmCORE) based study. Cancers (Basel). 2021;13(19).
Nakano H, Oussoultzoglou E, Rosso E, Casnedi S, Chenard-Neu MP, Dufour P, et al. Sinusoidal injury increases morbidity after major hepatectomy in patients with colorectal liver metastases receiving preoperative chemotherapy. Ann Surg. 2008;247(1):118–24.
pubmed: 18156931
Mehta NN, Ravikumar R, Coldham CA, Buckels JAC, Hubscher SG, Bramhall SR, et al. Effect of preoperative chemotherapy on liver resection for colorectal liver metastases. Eur J Surg Oncol. 2008;34(7):782–6.
pubmed: 18160247
Kemeny N. Presurgical chemotherapy in patients being considered for liver resection. Oncologist. 2007;12(7):825–39.
pubmed: 17673614
Aloia T, Sebagh M, Plasse M, Karam V, Lévi F, Giacchetti S, et al. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin Oncol. 2006;24(31):4983–90.
pubmed: 17075116
Kishi Y, Zorzi D, Contreras CM, Maru DM, Kopetz S, Ribero D, et al. Extended preoperative chemotherapy does not improve pathologic response and increases postoperative liver insufficiency after hepatic resection for colorectal liver metastases. Ann Surg Oncol. 2010;17(11):2870–6.
pubmed: 20567921
Karoui M, Penna C, Amin-Hashem M, Mitry E, Benoist S, Franc B, et al. Influence of preoperative chemotherapy on the risk of major hepatectomy for colorectal liver metastases. Ann Surg. 2006;243(1):1–7.
pubmed: 16371728
pmcid: 1449955
Valdimarsson VT, Hellberg K, Brismar TB, Sparrelid E, Sturesson C. Repeat procedures for recurrent colorectal liver metastases: analysis of long-term liver regeneration and outcome. Cancer Manag Res. 2019;11:2617–22.
pubmed: 31118767
pmcid: 6497974