Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study

P. Gibbs; V.J. Gebski; M. Van Buskirk; K.G. Thurston; D.N. Cade; Guy Van Hazel; P. Amin; B. Angelelli; J. Balosso; A.N. Beny; D. Bloomgarden; E. Boucher; M.P. Brown; H.R. Bruch; J. Bui; M.E. Burge; G.T. Cardaci; J. Carlisle; Y. Chen; P. Chevallier; S.J. Clarke; A.L. Coveler; M. Craninx; T. Delanoit; A. Deleporte; P.E. Eliadis; F. Facchini; T.R. Ferguson; M. Ferrante; M. Findlay; G.P. Frenette; J. Frick; V. Ganju; M. Garofalo; K. Geboes; G. Gehbauer; B. George; R. Geva; M. Gordon; S. Gulac; J. Hannigan; V. Heinemann; T. Helmberger; M. Holtzman; R. Isaacs; P. James; A. Kaubisch; Y. Ko; T. Kooy; H. Kröning; F. Lammert; W.S. Liauw; S. Louafi; M. De Man; J. Margolis; R. Martin; G. Marx; M. Matos; E. Monsaert; V. Moons; L. Nott; A. Nusch; A. O'Donnell; H. Ozer; S. Padia; N. Pavlakis; M.A. Peeters; D. Perez; S. Pluntke; M. Polus; A. Powell; T.J. Price; D.T. Ransom; C. Rebischung; K. Ridwelski; H. Riess; J.R. Riera; J. Ricke; W. Rilling; B.A. Robinson; J. Rodríguez; T. Sauerbruch; M. Savin; K. Scheidhauer; E. Schneiderman; G.R. Seeger; E. Segelov; E.S. Schmueli; A. Shani; J.A. Shannon; N. Sharma; S. Shibata; N. Singhal; D. Smith; R. Smith; S. Stemmer; O.J. Stötzer; A.H. Strickland; J. Taieb; K. Tatsch; E. Terrebonne; T.E. Tichler; U. Vehling-Kaiser; R. Vera García; T. Vogl; E.T. Walpole; E. Wang; S. Whiting; I. Wolf

doi:10.1186/1471-2407-14-897

Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study

P. Gibbs, V.J. Gebski, M. Van Buskirk, K.G. Thurston, D.N. Cade, Guy Van Hazel, P. Amin, B. Angelelli, J. Balosso, A.N. Beny, D. Bloomgarden, E. Boucher, M.P. Brown, H.R. Bruch, J. Bui, M.E. Burge, G.T. Cardaci, J. Carlisle, Y. Chen, P. ChevallierS.J. Clarke, A.L. Coveler, M. Craninx, T. Delanoit, A. Deleporte, P.E. Eliadis, F. Facchini, T.R. Ferguson, M. Ferrante, M. Findlay, G.P. Frenette, J. Frick, V. Ganju, M. Garofalo, K. Geboes, G. Gehbauer, B. George, R. Geva, M. Gordon, S. Gulac, J. Hannigan, V. Heinemann, T. Helmberger, M. Holtzman, R. Isaacs, P. James, A. Kaubisch, Y. Ko, T. Kooy, H. Kröning, F. Lammert, W.S. Liauw, S. Louafi, M. De Man, J. Margolis, R. Martin, G. Marx, M. Matos, E. Monsaert, V. Moons, L. Nott, A. Nusch, A. O'Donnell, H. Ozer, S. Padia, N. Pavlakis, M.A. Peeters, D. Perez, S. Pluntke, M. Polus, A. Powell, T.J. Price, D.T. Ransom, C. Rebischung, K. Ridwelski, H. Riess, J.R. Riera, J. Ricke, W. Rilling, B.A. Robinson, J. Rodríguez, T. Sauerbruch, M. Savin, K. Scheidhauer, E. Schneiderman, G.R. Seeger, E. Segelov, E.S. Schmueli, A. Shani, J.A. Shannon, N. Sharma, S. Shibata, N. Singhal, D. Smith, R. Smith, S. Stemmer, O.J. Stötzer, A.H. Strickland, J. Taieb, K. Tatsch, E. Terrebonne, T.E. Tichler, U. Vehling-Kaiser, R. Vera García, T. Vogl, E.T. Walpole, E. Wang, S. Whiting, I. Wolf

Research output: Contribution to journal › Article

36 Citations (Scopus)

Abstract

© 2014 Gibbs et al. Background: In colorectal cancer (CRC) unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres® Sirtex Medical Limited, North Sydney, Australia). Methods/Design: SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-native patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of ≥3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting ≥450 patients will be sufficient for 80% power and 95% confidence. Discussion: The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases. Trial registration: SIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008.

Original language	English
Pages (from-to)	1-10
Journal	BMC Cancer
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/1471-2407-14-897
Publication status	Published - 2014

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Gibbs, P., Gebski, V. J., Van Buskirk, M., Thurston, K. G., Cade, D. N., Van Hazel, G., Amin, P., Angelelli, B., Balosso, J., Beny, A. N., Bloomgarden, D., Boucher, E., Brown, M. P., Bruch, H. R., Bui, J., Burge, M. E., Cardaci, G. T., Carlisle, J., Chen, Y., ... Wolf, I. (2014). Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study. BMC Cancer, 14(1), 1-10. https://doi.org/10.1186/1471-2407-14-897

Gibbs, P. ; Gebski, V.J. ; Van Buskirk, M. ; Thurston, K.G. ; Cade, D.N. ; Van Hazel, Guy ; Amin, P. ; Angelelli, B. ; Balosso, J. ; Beny, A.N. ; Bloomgarden, D. ; Boucher, E. ; Brown, M.P. ; Bruch, H.R. ; Bui, J. ; Burge, M.E. ; Cardaci, G.T. ; Carlisle, J. ; Chen, Y. ; Chevallier, P. ; Clarke, S.J. ; Coveler, A.L. ; Craninx, M. ; Delanoit, T. ; Deleporte, A. ; Eliadis, P.E. ; Facchini, F. ; Ferguson, T.R. ; Ferrante, M. ; Findlay, M. ; Frenette, G.P. ; Frick, J. ; Ganju, V. ; Garofalo, M. ; Geboes, K. ; Gehbauer, G. ; George, B. ; Geva, R. ; Gordon, M. ; Gulac, S. ; Hannigan, J. ; Heinemann, V. ; Helmberger, T. ; Holtzman, M. ; Isaacs, R. ; James, P. ; Kaubisch, A. ; Ko, Y. ; Kooy, T. ; Kröning, H. ; Lammert, F. ; Liauw, W.S. ; Louafi, S. ; De Man, M. ; Margolis, J. ; Martin, R. ; Marx, G. ; Matos, M. ; Monsaert, E. ; Moons, V. ; Nott, L. ; Nusch, A. ; O'Donnell, A. ; Ozer, H. ; Padia, S. ; Pavlakis, N. ; Peeters, M.A. ; Perez, D. ; Pluntke, S. ; Polus, M. ; Powell, A. ; Price, T.J. ; Ransom, D.T. ; Rebischung, C. ; Ridwelski, K. ; Riess, H. ; Riera, J.R. ; Ricke, J. ; Rilling, W. ; Robinson, B.A. ; Rodríguez, J. ; Sauerbruch, T. ; Savin, M. ; Scheidhauer, K. ; Schneiderman, E. ; Seeger, G.R. ; Segelov, E. ; Schmueli, E.S. ; Shani, A. ; Shannon, J.A. ; Sharma, N. ; Shibata, S. ; Singhal, N. ; Smith, D. ; Smith, R. ; Stemmer, S. ; Stötzer, O.J. ; Strickland, A.H. ; Taieb, J. ; Tatsch, K. ; Terrebonne, E. ; Tichler, T.E. ; Vehling-Kaiser, U. ; Vera García, R. ; Vogl, T. ; Walpole, E.T. ; Wang, E. ; Whiting, S. ; Wolf, I. / Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study. In: BMC Cancer. 2014 ; Vol. 14, No. 1. pp. 1-10.

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title = "Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study",

abstract = "{\textcopyright} 2014 Gibbs et al. Background: In colorectal cancer (CRC) unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres{\textregistered} Sirtex Medical Limited, North Sydney, Australia). Methods/Design: SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-native patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of ≥3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting ≥450 patients will be sufficient for 80% power and 95% confidence. Discussion: The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases. Trial registration: SIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008.",

author = "P. Gibbs and V.J. Gebski and {Van Buskirk}, M. and K.G. Thurston and D.N. Cade and {Van Hazel}, Guy and P. Amin and B. Angelelli and J. Balosso and A.N. Beny and D. Bloomgarden and E. Boucher and M.P. Brown and H.R. Bruch and J. Bui and M.E. Burge and G.T. Cardaci and J. Carlisle and Y. Chen and P. Chevallier and S.J. Clarke and A.L. Coveler and M. Craninx and T. Delanoit and A. Deleporte and P.E. Eliadis and F. Facchini and T.R. Ferguson and M. Ferrante and M. Findlay and G.P. Frenette and J. Frick and V. Ganju and M. Garofalo and K. Geboes and G. Gehbauer and B. George and R. Geva and M. Gordon and S. Gulac and J. Hannigan and V. Heinemann and T. Helmberger and M. Holtzman and R. Isaacs and P. James and A. Kaubisch and Y. Ko and T. Kooy and H. Kr{\"o}ning and F. Lammert and W.S. Liauw and S. Louafi and {De Man}, M. and J. Margolis and R. Martin and G. Marx and M. Matos and E. Monsaert and V. Moons and L. Nott and A. Nusch and A. O'Donnell and H. Ozer and S. Padia and N. Pavlakis and M.A. Peeters and D. Perez and S. Pluntke and M. Polus and A. Powell and T.J. Price and D.T. Ransom and C. Rebischung and K. Ridwelski and H. Riess and J.R. Riera and J. Ricke and W. Rilling and B.A. Robinson and J. Rodr{\'i}guez and T. Sauerbruch and M. Savin and K. Scheidhauer and E. Schneiderman and G.R. Seeger and E. Segelov and E.S. Schmueli and A. Shani and J.A. Shannon and N. Sharma and S. Shibata and N. Singhal and D. Smith and R. Smith and S. Stemmer and O.J. St{\"o}tzer and A.H. Strickland and J. Taieb and K. Tatsch and E. Terrebonne and T.E. Tichler and U. Vehling-Kaiser and {Vera Garc{\'i}a}, R. and T. Vogl and E.T. Walpole and E. Wang and S. Whiting and I. Wolf",

year = "2014",

doi = "10.1186/1471-2407-14-897",

language = "English",

volume = "14",

pages = "1--10",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central",

number = "1",

}

Gibbs, P, Gebski, VJ, Van Buskirk, M, Thurston, KG, Cade, DN, Van Hazel, G, Amin, P, Angelelli, B, Balosso, J, Beny, AN, Bloomgarden, D, Boucher, E, Brown, MP, Bruch, HR, Bui, J, Burge, ME, Cardaci, GT, Carlisle, J, Chen, Y, Chevallier, P, Clarke, SJ, Coveler, AL, Craninx, M, Delanoit, T, Deleporte, A, Eliadis, PE, Facchini, F, Ferguson, TR, Ferrante, M, Findlay, M, Frenette, GP, Frick, J, Ganju, V, Garofalo, M, Geboes, K, Gehbauer, G, George, B, Geva, R, Gordon, M, Gulac, S, Hannigan, J, Heinemann, V, Helmberger, T, Holtzman, M, Isaacs, R, James, P, Kaubisch, A, Ko, Y, Kooy, T, Kröning, H, Lammert, F, Liauw, WS, Louafi, S, De Man, M, Margolis, J, Martin, R, Marx, G, Matos, M, Monsaert, E, Moons, V, Nott, L, Nusch, A, O'Donnell, A, Ozer, H, Padia, S, Pavlakis, N, Peeters, MA, Perez, D, Pluntke, S, Polus, M, Powell, A, Price, TJ, Ransom, DT, Rebischung, C, Ridwelski, K, Riess, H, Riera, JR, Ricke, J, Rilling, W, Robinson, BA, Rodríguez, J, Sauerbruch, T, Savin, M, Scheidhauer, K, Schneiderman, E, Seeger, GR, Segelov, E, Schmueli, ES, Shani, A, Shannon, JA, Sharma, N, Shibata, S, Singhal, N, Smith, D, Smith, R, Stemmer, S, Stötzer, OJ, Strickland, AH, Taieb, J, Tatsch, K, Terrebonne, E, Tichler, TE, Vehling-Kaiser, U, Vera García, R, Vogl, T, Walpole, ET, Wang, E, Whiting, S & Wolf, I 2014, 'Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study', BMC Cancer, vol. 14, no. 1, pp. 1-10. https://doi.org/10.1186/1471-2407-14-897

Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study. / Gibbs, P.; Gebski, V.J.; Van Buskirk, M.; Thurston, K.G.; Cade, D.N.; Van Hazel, Guy; Amin, P.; Angelelli, B.; Balosso, J.; Beny, A.N.; Bloomgarden, D.; Boucher, E.; Brown, M.P.; Bruch, H.R.; Bui, J.; Burge, M.E.; Cardaci, G.T.; Carlisle, J.; Chen, Y.; Chevallier, P.; Clarke, S.J.; Coveler, A.L.; Craninx, M.; Delanoit, T.; Deleporte, A.; Eliadis, P.E.; Facchini, F.; Ferguson, T.R.; Ferrante, M.; Findlay, M.; Frenette, G.P.; Frick, J.; Ganju, V.; Garofalo, M.; Geboes, K.; Gehbauer, G.; George, B.; Geva, R.; Gordon, M.; Gulac, S.; Hannigan, J.; Heinemann, V.; Helmberger, T.; Holtzman, M.; Isaacs, R.; James, P.; Kaubisch, A.; Ko, Y.; Kooy, T.; Kröning, H.; Lammert, F.; Liauw, W.S.; Louafi, S.; De Man, M.; Margolis, J.; Martin, R.; Marx, G.; Matos, M.; Monsaert, E.; Moons, V.; Nott, L.; Nusch, A.; O'Donnell, A.; Ozer, H.; Padia, S.; Pavlakis, N.; Peeters, M.A.; Perez, D.; Pluntke, S.; Polus, M.; Powell, A.; Price, T.J.; Ransom, D.T.; Rebischung, C.; Ridwelski, K.; Riess, H.; Riera, J.R.; Ricke, J.; Rilling, W.; Robinson, B.A.; Rodríguez, J.; Sauerbruch, T.; Savin, M.; Scheidhauer, K.; Schneiderman, E.; Seeger, G.R.; Segelov, E.; Schmueli, E.S.; Shani, A.; Shannon, J.A.; Sharma, N.; Shibata, S.; Singhal, N.; Smith, D.; Smith, R.; Stemmer, S.; Stötzer, O.J.; Strickland, A.H.; Taieb, J.; Tatsch, K.; Terrebonne, E.; Tichler, T.E.; Vehling-Kaiser, U.; Vera García, R.; Vogl, T.; Walpole, E.T.; Wang, E.; Whiting, S.; Wolf, I.

In: BMC Cancer, Vol. 14, No. 1, 2014, p. 1-10.

Research output: Contribution to journal › Article

TY - JOUR

T1 - Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study

AU - Gibbs, P.

AU - Gebski, V.J.

AU - Van Buskirk, M.

AU - Thurston, K.G.

AU - Cade, D.N.

AU - Van Hazel, Guy

AU - Amin, P.

AU - Angelelli, B.

AU - Balosso, J.

AU - Beny, A.N.

AU - Bloomgarden, D.

AU - Boucher, E.

AU - Brown, M.P.

AU - Bruch, H.R.

AU - Bui, J.

AU - Burge, M.E.

AU - Cardaci, G.T.

AU - Carlisle, J.

AU - Chen, Y.

AU - Chevallier, P.

AU - Clarke, S.J.

AU - Coveler, A.L.

AU - Craninx, M.

AU - Delanoit, T.

AU - Deleporte, A.

AU - Eliadis, P.E.

AU - Facchini, F.

AU - Ferguson, T.R.

AU - Ferrante, M.

AU - Findlay, M.

AU - Frenette, G.P.

AU - Frick, J.

AU - Ganju, V.

AU - Garofalo, M.

AU - Geboes, K.

AU - Gehbauer, G.

AU - George, B.

AU - Geva, R.

AU - Gordon, M.

AU - Gulac, S.

AU - Hannigan, J.

AU - Heinemann, V.

AU - Helmberger, T.

AU - Holtzman, M.

AU - Isaacs, R.

AU - James, P.

AU - Kaubisch, A.

AU - Ko, Y.

AU - Kooy, T.

AU - Kröning, H.

AU - Lammert, F.

AU - Liauw, W.S.

AU - Louafi, S.

AU - De Man, M.

AU - Margolis, J.

AU - Martin, R.

AU - Marx, G.

AU - Matos, M.

AU - Monsaert, E.

AU - Moons, V.

AU - Nott, L.

AU - Nusch, A.

AU - O'Donnell, A.

AU - Ozer, H.

AU - Padia, S.

AU - Pavlakis, N.

AU - Peeters, M.A.

AU - Perez, D.

AU - Pluntke, S.

AU - Polus, M.

AU - Powell, A.

AU - Price, T.J.

AU - Ransom, D.T.

AU - Rebischung, C.

AU - Ridwelski, K.

AU - Riess, H.

AU - Riera, J.R.

AU - Ricke, J.

AU - Rilling, W.

AU - Robinson, B.A.

AU - Rodríguez, J.

AU - Sauerbruch, T.

AU - Savin, M.

AU - Scheidhauer, K.

AU - Schneiderman, E.

AU - Seeger, G.R.

AU - Segelov, E.

AU - Schmueli, E.S.

AU - Shani, A.

AU - Shannon, J.A.

AU - Sharma, N.

AU - Shibata, S.

AU - Singhal, N.

AU - Smith, D.

AU - Smith, R.

AU - Stemmer, S.

AU - Stötzer, O.J.

AU - Strickland, A.H.

AU - Taieb, J.

AU - Tatsch, K.

AU - Terrebonne, E.

AU - Tichler, T.E.

AU - Vehling-Kaiser, U.

AU - Vera García, R.

AU - Vogl, T.

AU - Walpole, E.T.

AU - Wang, E.

AU - Whiting, S.

AU - Wolf, I.

PY - 2014

Y1 - 2014

N2 - © 2014 Gibbs et al. Background: In colorectal cancer (CRC) unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres® Sirtex Medical Limited, North Sydney, Australia). Methods/Design: SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-native patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of ≥3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting ≥450 patients will be sufficient for 80% power and 95% confidence. Discussion: The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases. Trial registration: SIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008.

AB - © 2014 Gibbs et al. Background: In colorectal cancer (CRC) unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres® Sirtex Medical Limited, North Sydney, Australia). Methods/Design: SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-native patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of ≥3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting ≥450 patients will be sufficient for 80% power and 95% confidence. Discussion: The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases. Trial registration: SIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008.

U2 - 10.1186/1471-2407-14-897

DO - 10.1186/1471-2407-14-897

M3 - Article

C2 - 25487708

VL - 14

SP - 1

EP - 10

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

IS - 1

ER -

Gibbs P, Gebski VJ, Van Buskirk M, Thurston KG, Cade DN, Van Hazel G et al. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study. BMC Cancer. 2014;14(1):1-10. https://doi.org/10.1186/1471-2407-14-897