Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)

W. J. Koemans; R. T. van der Kaaij; H. Boot; T. Buffart; A. A. F. A. Veenhof; K. J. Hartemink; C. Grootscholten; P. Snaebjornsson; V. P. Retel; H. van Tinteren; S. Vanhoutvin; V. van der Noort; A. Houwink; C. Hahn; A. D. R. Huitema; M. Lahaye; M. Los; P. van den Barselaar; O. Imhof; A. Aalbers; G. M. van Dam; B. van Etten; B. P. L. Wijnhoven; M. D. P. Luyer; D. Boerma; J. W. van Sandick

doi:10.1186/s12885-019-5640-2

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)

W. J. Koemans^*, R. T. van der Kaaij, H. Boot, T. Buffart, A. A. F. A. Veenhof, K. J. Hartemink, C. Grootscholten, P. Snaebjornsson, V. P. Retel, H. van Tinteren, S. Vanhoutvin, V. van der Noort, A. Houwink, C. Hahn, A. D. R. Huitema, M. Lahaye, M. Los, P. van den Barselaar, O. Imhof, A. AalbersG. M. van Dam, B. van Etten, B. P. L. Wijnhoven, M. D. P. Luyer, D. Boerma, J. W. van Sandick

^*Corresponding author for this work

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Abstract

BackgroundAt present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients.The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy.MethodsIn this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index

Original language	English
Article number	420
Number of pages	8
Journal	BMC Cancer
Volume	19
DOIs	https://doi.org/10.1186/s12885-019-5640-2
Publication status	Published - 6-May-2019

Keywords

Hyperthermic intraperitoneal chemotherapy
HIPEC
Peritoneal metastasis
Peritonitis carcinomatosa
Gastric cancer
Cytoreductive surgery
Palliative systemic chemotherapy
Gastrectomy
Surgery
POOLED ANALYSIS
CARCINOMATOSIS
OXALIPLATIN
SELECTION
RESECTION

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Koemans, W. J., van der Kaaij, R. T., Boot, H., Buffart, T., Veenhof, A. A. F. A., Hartemink, K. J., Grootscholten, C., Snaebjornsson, P., Retel, V. P., van Tinteren, H., Vanhoutvin, S., van der Noort, V., Houwink, A., Hahn, C., Huitema, A. D. R., Lahaye, M., Los, M., van den Barselaar, P., Imhof, O., ... van Sandick, J. W. (2019). Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer, 19, Article 420. https://doi.org/10.1186/s12885-019-5640-2

@article{029d756011f343898c9bbd17b3629bfc,

title = "Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)",

abstract = "BackgroundAt present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients.The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy.MethodsIn this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index",

keywords = "Hyperthermic intraperitoneal chemotherapy, HIPEC, Peritoneal metastasis, Peritonitis carcinomatosa, Gastric cancer, Cytoreductive surgery, Palliative systemic chemotherapy, Gastrectomy, Surgery, POOLED ANALYSIS, CARCINOMATOSIS, OXALIPLATIN, SELECTION, RESECTION",

author = "Koemans, {W. J.} and {van der Kaaij}, {R. T.} and H. Boot and T. Buffart and Veenhof, {A. A. F. A.} and Hartemink, {K. J.} and C. Grootscholten and P. Snaebjornsson and Retel, {V. P.} and {van Tinteren}, H. and S. Vanhoutvin and {van der Noort}, V. and A. Houwink and C. Hahn and Huitema, {A. D. R.} and M. Lahaye and M. Los and {van den Barselaar}, P. and O. Imhof and A. Aalbers and {van Dam}, {G. M.} and {van Etten}, B. and Wijnhoven, {B. P. L.} and Luyer, {M. D. P.} and D. Boerma and {van Sandick}, {J. W.}",

year = "2019",

month = may,

day = "6",

doi = "10.1186/s12885-019-5640-2",

language = "English",

volume = "19",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BMC",

}

Koemans, WJ, van der Kaaij, RT, Boot, H, Buffart, T, Veenhof, AAFA, Hartemink, KJ, Grootscholten, C, Snaebjornsson, P, Retel, VP, van Tinteren, H, Vanhoutvin, S, van der Noort, V, Houwink, A, Hahn, C, Huitema, ADR, Lahaye, M, Los, M, van den Barselaar, P, Imhof, O, Aalbers, A, van Dam, GM , van Etten, B, Wijnhoven, BPL, Luyer, MDP, Boerma, D & van Sandick, JW 2019, 'Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)', BMC Cancer, vol. 19, 420. https://doi.org/10.1186/s12885-019-5640-2

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). / Koemans, W. J.; van der Kaaij, R. T.; Boot, H. et al.
In: BMC Cancer, Vol. 19, 420, 06.05.2019.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)

AU - Koemans, W. J.

AU - van der Kaaij, R. T.

AU - Boot, H.

AU - Buffart, T.

AU - Veenhof, A. A. F. A.

AU - Hartemink, K. J.

AU - Grootscholten, C.

AU - Snaebjornsson, P.

AU - Retel, V. P.

AU - van Tinteren, H.

AU - Vanhoutvin, S.

AU - van der Noort, V.

AU - Houwink, A.

AU - Hahn, C.

AU - Huitema, A. D. R.

AU - Lahaye, M.

AU - Los, M.

AU - van den Barselaar, P.

AU - Imhof, O.

AU - Aalbers, A.

AU - van Dam, G. M.

AU - van Etten, B.

AU - Wijnhoven, B. P. L.

AU - Luyer, M. D. P.

AU - Boerma, D.

AU - van Sandick, J. W.

PY - 2019/5/6

Y1 - 2019/5/6

N2 - BackgroundAt present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients.The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy.MethodsIn this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index

AB - BackgroundAt present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients.The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy.MethodsIn this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index

KW - Hyperthermic intraperitoneal chemotherapy

KW - HIPEC

KW - Peritoneal metastasis

KW - Peritonitis carcinomatosa

KW - Gastric cancer

KW - Cytoreductive surgery

KW - Palliative systemic chemotherapy

KW - Gastrectomy

KW - Surgery

KW - POOLED ANALYSIS

KW - CARCINOMATOSIS

KW - OXALIPLATIN

KW - SELECTION

KW - RESECTION

U2 - 10.1186/s12885-019-5640-2

DO - 10.1186/s12885-019-5640-2

M3 - Article

SN - 1471-2407

VL - 19

JO - BMC Cancer

JF - BMC Cancer

M1 - 420

ER -

Koemans WJ, van der Kaaij RT, Boot H, Buffart T, Veenhof AAFA, Hartemink KJ et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer. 2019 May 6;19:420. doi: 10.1186/s12885-019-5640-2