Treatment of peritoneal dissemination in stomach cancer patients with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy; PERISCOPE-2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

28 Sep 2017 → ongoing

Decision date (initial)

2025-01-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-510159-53-01

EudraCT number

2015-005695-15

ClinicalTrials.gov

NCT03348150

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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. systemic palliative chemotherapy.

Secondary objectives 5

1. 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.
2. 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.
3. 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.
4. To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional)
5. To investigate the pharmacokinetics and penetration depth of intra-abdominal oxaliplatin and docetaxel after gastrectomy and cytoreductive surgery. (optional)

Conditions and MedDRA coding

peritoneal dissemination in stomach cancer patients

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Age ≥ 18 years
2. 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.
3. cT3-cT4 tumour (TNM classification, 7th edition(47)), considered to be resectable (including lymph nodes)
4. Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy (paragraph 5.3.1 and 6.2) and proven by pathological examination
5. Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion.
6. Absence of disease progression during systemic chemotherapy (prior to inclusion)
7. WHO performance status 0-2
8. Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion: o White blood cell count (WBC) >3.0*109/LPlatelet count ≥ 100 x 109 /L o Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN o Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
9. For female patients who are not sterilised or in menopause: o negative pregnancy test (urine/serum) o no breast feeding or active pregnancy ambition o reliable contraceptive methods
10. Signed informed consent

Exclusion criteria 12

1. Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
2. Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
3. Recurrent gastric cancer
4. Prior resection of the primary gastric tumour
5. Non-synchronous peritoneal carcinomatosis
6. Current other malignancy (other than cervix carcinoma and basalioma)
7. Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
8. A known history of hepatitis B or C with active viral replication
9. Recent myocardial infarction (< 6 months) or unstable angina
10. 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
11. Uncontrolled diabetes mellitus
12. Pregnancy or breast feeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival

Secondary endpoints 6

1. Progression free survival
2. Treatment-related toxicity
3. Costs and resource use
4. Quality of life
5. Genetic profiles related to tumour response (optional)
6. pharmacokinetics and penetration depth of oxaliplatin and docetaxel (optional)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Judith Quik

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Judith Quik

Locations

4 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications