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17 results on '"Constantinides, Alexander"'

1. Consensus molecular subtype 4 (CMS4)-targeted therapy in primary colon cancer: A proof-of-concept study

Author

Peters, Niek A., Constantinides, Alexander, Ubink, Inge, Kuik, Joyce van, Bloemendal, H.J., Dodewaard, Joyce M. van, Borel Rinkes, Inne H. M., Kranenburg, Onno, Peters, Niek A., Constantinides, Alexander, Ubink, Inge, Kuik, Joyce van, Bloemendal, H.J., Dodewaard, Joyce M. van, Borel Rinkes, Inne H. M., and Kranenburg, Onno

Abstract

Contains fulltext : 283950.pdf (Publisher’s version ) (Open Access)

Published
2022

2. Consensus molecular subtype 4 (CMS4)-targeted therapy in primary colon cancer: A proof-of-concept study

Author

Peters, Niek A., Constantinides, Alexander, Ubink, Inge, Kuik, Joyce van, Bloemendal, H.J., Dodewaard, Joyce M. van, Borel Rinkes, Inne H. M., Kranenburg, Onno, Peters, Niek A., Constantinides, Alexander, Ubink, Inge, Kuik, Joyce van, Bloemendal, H.J., Dodewaard, Joyce M. van, Borel Rinkes, Inne H. M., and Kranenburg, Onno

Abstract

Contains fulltext : 283950.pdf (Publisher’s version ) (Open Access)

Published
2022

3. Consensus molecular subtype 4 (CMS4)-targeted therapy in primary colon cancer:A proof-of-concept study

Author

Peters, Niek A., Constantinides, Alexander, Ubink, Inge, van Kuik, Joyce, Bloemendal, Haiko J., van Dodewaard, Joyce M., Brink, Menno A., Schwartz, Thijs P., Lolkema, Martijn P.J.K., Lacle, Miangela M., Moons, Leon M., Geesing, Joost, van Grevenstein, Wilhelmina M.U., Roodhart, Jeanine M.L., Koopman, Miriam, Elias, Sjoerd G., Borel Rinkes, Inne H.M., Kranenburg, Onno, Peters, Niek A., Constantinides, Alexander, Ubink, Inge, van Kuik, Joyce, Bloemendal, Haiko J., van Dodewaard, Joyce M., Brink, Menno A., Schwartz, Thijs P., Lolkema, Martijn P.J.K., Lacle, Miangela M., Moons, Leon M., Geesing, Joost, van Grevenstein, Wilhelmina M.U., Roodhart, Jeanine M.L., Koopman, Miriam, Elias, Sjoerd G., Borel Rinkes, Inne H.M., and Kranenburg, Onno

Abstract

Background: Mesenchymal Consensus Molecular Subtype 4 (CMS4) colon cancer is associated with poor prognosis and therapy resistance. In this proof-of-concept study, we assessed whether a rationally chosen drug could mitigate the distinguishing molecular features of primary CMS4 colon cancer. Methods: In the ImPACCT trial, informed consent was obtained for molecular subtyping at initial diagnosis of colon cancer using a validated RT-qPCR CMS4-test on three biopsies per tumor (Phase-1, n=69 patients), and for neoadjuvant CMS4-targeting therapy with imatinib (Phase-2, n=5). Pre- and post-treatment tumor biopsies were analyzed by RNA-sequencing and immunohistochemistry. Imatinib-induced gene expression changes were associated with molecular subtypes and survival in an independent cohort of 3232 primary colon cancer. Results: The CMS4-test classified 52/172 biopsies as CMS4 (30%). Five patients consented to imatinib treatment prior to surgery, yielding 15 pre- and 15 post-treatment samples for molecular analysis. Imatinib treatment caused significant suppression of mesenchymal genes and upregulation of genes encoding epithelial junctions. The gene expression changes induced by imatinib were associated with improved survival and a shift from CMS4 to CMS2. Conclusion: Imatinib may have value as a CMS-switching drug in primary colon cancer and induces a gene expression program that is associated with improved survival.

Published
2022

4. Consensus molecular subtype 4 (CMS4)-targeted therapy in primary colon cancer: A proof-of-concept study

Author

Lab Translational Oncology, Cancer, MS CGO, Pathologie Moleculair Path., MS Medische Oncologie, RF&S Team 2 Medisch, Medisch Oncologische Disciplines, Pathologie Pathologen staf, MS MDL 1, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Regenerative Medicine and Stem Cells, Peters, Niek A., Constantinides, Alexander, Ubink, Inge, van Kuik, Joyce, Bloemendal, Haiko J., van Dodewaard, Joyce M., Brink, Menno A., Schwartz, Thijs P., Lolkema, Martijn P.J.K., Lacle, Miangela M., Moons, Leon M., Geesing, Joost, van Grevenstein, Wilhelmina M.U., Roodhart, Jeanine M.L., Koopman, Miriam, Elias, Sjoerd G., Borel Rinkes, Inne H.M., Kranenburg, Onno, Lab Translational Oncology, Cancer, MS CGO, Pathologie Moleculair Path., MS Medische Oncologie, RF&S Team 2 Medisch, Medisch Oncologische Disciplines, Pathologie Pathologen staf, MS MDL 1, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Regenerative Medicine and Stem Cells, Peters, Niek A., Constantinides, Alexander, Ubink, Inge, van Kuik, Joyce, Bloemendal, Haiko J., van Dodewaard, Joyce M., Brink, Menno A., Schwartz, Thijs P., Lolkema, Martijn P.J.K., Lacle, Miangela M., Moons, Leon M., Geesing, Joost, van Grevenstein, Wilhelmina M.U., Roodhart, Jeanine M.L., Koopman, Miriam, Elias, Sjoerd G., Borel Rinkes, Inne H.M., and Kranenburg, Onno

Published
2022

5. Peritoneal metastases from colorectal cancer belong to Consensus Molecular Subtype 4 and are sensitised to oxaliplatin by inhibiting reducing capacity

Author

Lab Translational Oncology, Cancer, MS CGO, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Apotheek O&O&O, Regenerative Medicine and Stem Cells, Laoukili, Jamila, Constantinides, Alexander, Wassenaar, Emma C E, Elias, Sjoerd G, Raats, Danielle A E, van Schelven, Susanne J, van Wettum, Jonathan, Volckmann, Richard, Koster, Jan, Huitema, Alwin D R, Nienhuijs, Simon W, de Hingh, Ignace H J T, Wiezer, René J, van Grevenstein, Helma M U, Rinkes, Inne H M Borel, Boerma, Djamila, Kranenburg, Onno, Lab Translational Oncology, Cancer, MS CGO, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Apotheek O&O&O, Regenerative Medicine and Stem Cells, Laoukili, Jamila, Constantinides, Alexander, Wassenaar, Emma C E, Elias, Sjoerd G, Raats, Danielle A E, van Schelven, Susanne J, van Wettum, Jonathan, Volckmann, Richard, Koster, Jan, Huitema, Alwin D R, Nienhuijs, Simon W, de Hingh, Ignace H J T, Wiezer, René J, van Grevenstein, Helma M U, Rinkes, Inne H M Borel, Boerma, Djamila, and Kranenburg, Onno

Published
2022

6. First-line palliative systemic therapy alternated with electrostatic pressurised intraperitoneal aerosol chemotherapy (oxaliplatin) for isolated unresectable colorectal peritoneal metastases: Protocol of a multicentre, single-arm, phase II study (CRC-PIPAC-II)

Author

Research UMC Utrecht, Lab Translational Oncology, Cancer, Regenerative Medicine and Stem Cells, Lurvink, Robin J., Rauwerdink, Paulien, Rovers, Koen P., Wassenaar, Emma C.E., Deenen, Maarten J., Nederend, Joost, Huysentruyt, Clément J.R., Van 'T Erve, Iris, Fijneman, Remond J.A., Van Der Hoeven, Erik J.R.J., Seldenrijk, Cornelis A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Herbschleb, Karin H., Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Nienhuijs, Simon W., Boerma, Djamila, De Hingh, Ignace H.J.T., Research UMC Utrecht, Lab Translational Oncology, Cancer, Regenerative Medicine and Stem Cells, Lurvink, Robin J., Rauwerdink, Paulien, Rovers, Koen P., Wassenaar, Emma C.E., Deenen, Maarten J., Nederend, Joost, Huysentruyt, Clément J.R., Van 'T Erve, Iris, Fijneman, Remond J.A., Van Der Hoeven, Erik J.R.J., Seldenrijk, Cornelis A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Herbschleb, Karin H., Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Nienhuijs, Simon W., Boerma, Djamila, and De Hingh, Ignace H.J.T.

Published
2021

7. Detection of tumor-derived cell-free DNA from colorectal cancer peritoneal metastases in plasma and peritoneal fluid

Author

MS HOD, Lab Translational Oncology, Cancer, Regenerative Medicine and Stem Cells, van't Erve, Iris, Rovers, Koen P., Constantinides, Alexander, Bolhuis, Karen, Wassenaar, Emma C.E., Lurvink, Robin J., Huysentruyt, Clément J., Snaebjornsson, Petur, Boerma, Djamila, van den Broek, Daan, Buffart, Tineke E., Lahaye, Max J., Aalbers, Arend G.J., Kok, Niels F.M., Meijer, Gerrit A., Punt, Cornelis J.A., Kranenburg, Onno, de Hingh, Ignace H.J.T., Fijneman, Remond J.A., MS HOD, Lab Translational Oncology, Cancer, Regenerative Medicine and Stem Cells, van't Erve, Iris, Rovers, Koen P., Constantinides, Alexander, Bolhuis, Karen, Wassenaar, Emma C.E., Lurvink, Robin J., Huysentruyt, Clément J., Snaebjornsson, Petur, Boerma, Djamila, van den Broek, Daan, Buffart, Tineke E., Lahaye, Max J., Aalbers, Arend G.J., Kok, Niels F.M., Meijer, Gerrit A., Punt, Cornelis J.A., Kranenburg, Onno, de Hingh, Ignace H.J.T., and Fijneman, Remond J.A.

Published
2021

8. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H. J. T., Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H. J. T.

Published
2019

9. Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin : Protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial

Author

De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, Burger, Jacobus W.A., De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, and Burger, Jacobus W.A.

Published
2019

10. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C.E., Kootstra, Thomas J.M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clément J.R., van 't Erve, Iris, Fijneman, Remond J.SA., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H.J.T., Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C.E., Kootstra, Thomas J.M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clément J.R., van 't Erve, Iris, Fijneman, Remond J.SA., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H.J.T.

Abstract

Introduction: Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide. However, little is known about its feasibility, safety, tolerability, efficacy, costs and pharmacokinetics in this setting. This study aims to explore these parameters in patients with isolated unresectable colorectal PM who receive repetitive ePIPAC-OX as a palliative monotherapy. Methods and analysis: This multicentre, open-label, single-arm, phase II study is performed in two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM. Eligible patients are adults who have histologically or cytologically proven isolated unresectable PM of a colorectal or appendiceal carcinoma, a good performance status, adequate organ functions and no symptoms of gastrointestinal obstruction. Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled ePIPAC-OX (92 mg/m 2 body surface area (BSA)) with intravenous leucovorin (20 mg/m 2 BSA) and bolus 5-fluorouracil (400 mg/m 2 BSA) every 6 weeks. Four weeks after each procedure, patients undergo clinical, radiological and biochemical evaluation. ePIPAC-OX is repeated until disease progression, after which standard palliative treatment is (re)considered. The primary outcome is the number of patients with major toxicity (grade ≥3 according to the Common Terminology Criteria for Adverse Events v4.0) up to 4 weeks after the last ePIPAC-OX. Secondary outcomes are the environmental safety of ePIPAC-OX, procedure-related characteristics, minor toxicity, postoperative complications, hospital stay, readmissions, quality of life, costs, pharmacokinetics of oxaliplatin, progression-free survival, overall survival, and the radiological, histopathological, cytological, biochemical and macroscopic

Published
2019

11. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H. J. T., Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H. J. T.

Published
2019

12. Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin : Protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial

Author

De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, Burger, Jacobus W.A., De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, and Burger, Jacobus W.A.

Published
2019

13. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H. J. T., Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H. J. T.

Published
2019

14. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

MS CGO, CMM Groep Coffer, Cancer, Regenerative Medicine and Stem Cells, Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H. J. T., MS CGO, CMM Groep Coffer, Cancer, Regenerative Medicine and Stem Cells, Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C. E., Kootstra, Thomas J. M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clement J. R., van't Erve, Iris, Fijneman, Remond J. A., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M. J., Creemers, Geert-Jan M., Burger, Jacobus W. A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H. J. T.

Published
2019

15. Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin: Protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial

Author

CMM Groep Coffer, MS CGO, Regenerative Medicine and Stem Cells, Cancer, De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, Burger, Jacobus W.A., CMM Groep Coffer, MS CGO, Regenerative Medicine and Stem Cells, Cancer, De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, and Burger, Jacobus W.A.

Published
2019

16. Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Author

Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C.E., Kootstra, Thomas J.M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clément J.R., van 't Erve, Iris, Fijneman, Remond J.SA., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., de Hingh, Ignace H.J.T., Rovers, Koen P., Lurvink, Robin J., Wassenaar, Emma C.E., Kootstra, Thomas J.M., Scholten, Harm J., Tajzai, Rudaba, Deenen, Maarten J., Nederend, Joost, Lahaye, Max J., Huysentruyt, Clément J.R., van 't Erve, Iris, Fijneman, Remond J.SA., Constantinides, Alexander, Kranenburg, Onno, Los, Maartje, Thijs, Anna M.J., Creemers, Geert Jan M., Burger, Jacobus W.A., Wiezer, Marinus J., Boerma, Djamila, Nienhuijs, Simon W., and de Hingh, Ignace H.J.T.

Abstract

Introduction: Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide. However, little is known about its feasibility, safety, tolerability, efficacy, costs and pharmacokinetics in this setting. This study aims to explore these parameters in patients with isolated unresectable colorectal PM who receive repetitive ePIPAC-OX as a palliative monotherapy. Methods and analysis: This multicentre, open-label, single-arm, phase II study is performed in two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM. Eligible patients are adults who have histologically or cytologically proven isolated unresectable PM of a colorectal or appendiceal carcinoma, a good performance status, adequate organ functions and no symptoms of gastrointestinal obstruction. Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled ePIPAC-OX (92 mg/m 2 body surface area (BSA)) with intravenous leucovorin (20 mg/m 2 BSA) and bolus 5-fluorouracil (400 mg/m 2 BSA) every 6 weeks. Four weeks after each procedure, patients undergo clinical, radiological and biochemical evaluation. ePIPAC-OX is repeated until disease progression, after which standard palliative treatment is (re)considered. The primary outcome is the number of patients with major toxicity (grade ≥3 according to the Common Terminology Criteria for Adverse Events v4.0) up to 4 weeks after the last ePIPAC-OX. Secondary outcomes are the environmental safety of ePIPAC-OX, procedure-related characteristics, minor toxicity, postoperative complications, hospital stay, readmissions, quality of life, costs, pharmacokinetics of oxaliplatin, progression-free survival, overall survival, and the radiological, histopathological, cytological, biochemical and macroscopic

Published
2019

17. Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin:Protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial

Author

De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, Burger, Jacobus W.A., De Boer, Nadine Leonie, Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., DIepeveen, Marjolein, Van Meerten, Esther, Van Eerden, Ruben A.G., De Man, Femke M., Bouamar, Rachida, Koolen, Stijn L.W., De Hingh, Ignace H.J.T., Bakkers, Checca, Rovers, Koen P., Creemers, Geert Jan M., Deenen, Maarten J., Kranenburg, Onno W., Constantinides, Alexander, Mathijssen, Ron H.J., Verhoef, Cornelis, and Burger, Jacobus W.A.

Abstract

Introduction Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) has become standard of care for patients with peritoneal metastases of colorectal origin with a low/moderate abdominal disease load. In case of a peritoneal cancer index (PCI) score >20, CRS-HIPEC is not considered to be beneficial. Patients with a PCI >20 are currently offered palliative systemic chemotherapy. Previous studies have shown that systemic chemotherapy is less effective against peritoneal metastases than it is against haematogenous spread of colorectal cancer. It is suggested that patients with peritoneal metastases may benefit from the addition of intraperitoneal chemotherapy to systemic chemotherapy. Aim of this study is to establish the maximum tolerated dose of intraperitoneal irinotecan, added to standard of care systemic therapy for colorectal cancer. Secondary endpoints are to determine the safety and feasibility of this treatment and to establish the pharmacokinetic profile of intraperitoneally administered irinotecan. Methods and analysis This phase I, '3+3' dose-escalation, study is performed in two Dutch tertiary referral centres. The study population consists of adult patients with extensive peritoneal metastases of colorectal origin who have a good performance status and no extra-Abdominal metastases. According to standard work-up for CRS-HIPEC, patients will undergo a diagnostic laparoscopy to score the PCI. In case of a PCI >20, a peritoneal access port will be placed in the abdomen of the patient. Through this port we will administer intraperitoneal irinotecan, in combination with standard systemic treatment consisting of 5-fluorouracil/leucovorin with oxaliplatin and the targeted agent bevacizumab. Therapy consists of a maximum of 12 cycles 2-weekly. Ethics and dissemination This study protocol is approved by a research medical ethics committee (Rotterdam, Netherlands) and the Dutch Competent Authority (CCMO, The Hague, Netherlands).

Published
2019

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