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Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination. (PERISCOPE II)

Primary Purpose

Stomach Neoplasm, Peritoneal Carcinomatosis

Status

Recruiting

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

Cytoreductive surgery + Gastrecomy

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring HIPEC, Hyperthermic Intraperitoneal Chemotherapy, gastrectomy, cytoreductive surgery, oxaliplatin, docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes)
Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination
Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable
Absence of disease progression during systemic chemotherapy (prior to inclusion)
WHO performance status 0-2
Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion:
- ANC ≥ 1.5 x 109 /L
- Platelet count ≥ 100 x 109 /L
- Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
- Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
For female patients who are not sterilised or in menopause (i.e., amenorrhea ≥1 year if age ≥60 years, or ≥2 years if age <60 years):
- negative pregnancy test (urine/serum)
- no breast feeding or active pregnancy ambition
- reliable contraceptive methods
Signed informed consent

Exclusion Criteria:

Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
Recurrent gastric cancer
Prior resection of the primary gastric tumour
Non-synchronous peritoneal carcinomatosis
Current other malignancy (other than cervix carcinoma and basalioma)
Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
A known history of hepatitis B or C with active viral replication
Recent myocardial infarction (< 6 months) or unstable angina
Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Sites / Locations

Antoni van Leeuwenhoek/ Netherlands Cancer instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gastrecomy + Cytoreductive surgery + HIPEC

palliative systemic chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

overall survival

To compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.

Secondary Outcome Measures

progression free survival

To compare the progression free survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.

treatment-related toxicity

To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC.

costs and health benefits

To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology.

Full Information

NCT ID

NCT03348150

First Posted

November 15, 2017

Last Updated

February 14, 2022

Sponsor

The Netherlands Cancer Institute

Collaborators

Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen, Catharina Ziekenhuis Eindhoven

1. Study Identification

Unique Protocol Identification Number

NCT03348150

Brief Title

Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.

Acronym

PERISCOPE II

Official Title

Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

October 1, 2026 (Anticipated)

Study Completion Date

October 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

Collaborators

Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen, Catharina Ziekenhuis Eindhoven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).

Detailed Description

Rationale: For gastric cancer patients with peritoneal carcinomatosis palliative systemic chemotherapy is the standard treatment in the Netherlands. There are no potentially curative treatment options. Peritoneal carcinomatosis, in contrast to lymphatic and haematogenous dissemination, should be regarded as locoregional extension of disease. Administering chemotherapeutic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations of cytotoxic drugs can be delivered directly into the peritoneal cavity with little systemic toxicity. The combination of intraperitoneally administered chemotherapy with cytoreductive surgery and a radical gastrectomy has shown promising results in gastric cancer patients in Asia. As with other gastric cancer issues, the results obtained in Asian patients cannot be extrapolated directly to Western patients. Objective: The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy. Study design : This is a multicentre randomised controlled two-armed phase III trial. Patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment). Study population: Gastric cancer patients are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal carcinomatosis (<7) and/ or tumour positive cytology is confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy (prior to inclusion) was without disease progression. Main study parameters/endpoints: The study sample size (182 patients) is calculated from the hypothesis that the median overall survival of the patients treated according to protocol in the experimental arm is 18 months, as compared to a median overall survival of 10 months in the standard arm. Statistical analysis will be done according to the intention-to-treat principle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasm, Peritoneal Carcinomatosis

Keywords

HIPEC, Hyperthermic Intraperitoneal Chemotherapy, gastrectomy, cytoreductive surgery, oxaliplatin, docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

1:1 randomization

Masking

None (Open Label)

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastrecomy + Cytoreductive surgery + HIPEC

Arm Type

Experimental

Arm Title

palliative systemic chemotherapy

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Cytoreductive surgery + Gastrecomy

Intervention Description

Complete cytoreduction followed by a (sub)total gastric resection with D2 lymphadenectomy.

Intervention Type

Drug

Intervention Name(s)

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Intervention Description

HIPEC: perfusion with oxaliplatin (460mg/m2 ) (42 °C) followed by docetaxel (50mg/m2 ) (37°C)

Primary Outcome Measure Information:

Title

overall survival

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

progression free survival

Description

Time Frame

5 years

Title

treatment-related toxicity

Description

Time Frame

5 years

Title

costs and health benefits

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary. cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes) Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable Absence of disease progression during systemic chemotherapy (prior to inclusion) WHO performance status 0-2 Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion: ANC ≥ 1.5 x 109 /L Platelet count ≥ 100 x 109 /L Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula) For female patients who are not sterilised or in menopause (i.e., amenorrhea ≥1 year if age ≥60 years, or ≥2 years if age <60 years): negative pregnancy test (urine/serum) no breast feeding or active pregnancy ambition reliable contraceptive methods Signed informed consent Exclusion Criteria: Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination Recurrent gastric cancer Prior resection of the primary gastric tumour Non-synchronous peritoneal carcinomatosis Current other malignancy (other than cervix carcinoma and basalioma) Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2 A known history of hepatitis B or C with active viral replication Recent myocardial infarction (< 6 months) or unstable angina Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen van der Sluis, MSc

Phone

+31 20 512 2954

k.vd.sluis@nki.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johanna van Sandick, MD, PHD

Organizational Affiliation

Surgeon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antoni van Leeuwenhoek/ Netherlands Cancer institute

City

Amsterdam

ZIP/Postal Code

1066CZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen van der Sluis, MSc

Phone

+31 20 512 2954

k.vd.sluis@nki.nl

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28705789

Citation

van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.

Results Reference

background

PubMed Identifier

31060544

Citation

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. 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(1):420. doi: 10.1186/s12885-019-5640-2.

Results Reference

derived

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Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.

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