Clinical Trials Register

Summary
EudraCT Number:	2015-005695-15
Sponsor's Protocol Code Number:	NL56123.031.15
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-11-14
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2015-005695-15

A.3

Full title of the trial

Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study

Behandeling van het peritoneaal gemetastaseerde maagcarcinoom met cytoreductie en hypertherme intraperitoneale chemotherapie (HIPEC): de PERISCOPE II studie.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.

Een wetenschappelijk onderzoek bij maagkankerpatiënten met uitzaaiingen op het buikvlies naar het effect van een operatie in combinatie met verwarmde chemotherapie in de buikholte (HIPEC) vergeleken met de standaard behandeling bestaande uit systemische chemotherapie.

A.3.2

Name or abbreviated title of the trial where available

PERISCOPE II-study

PERISCOPE II-studie

A.4.1

Sponsor's protocol code number

NL56123.031.15

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	NKI-AVL
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Nederlands Kanker Instituut - Antoni van Leeuwenhoek
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	NKI-AVL
B.5.2	Functional name of contact point	Trial Bureau
B.5.3	Address:
B.5.3.1	Street Address	Plesmanlaan 121
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1066 CX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310205127496
B.5.6	E-mail	trial@nki.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Eloxatin
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis Netherlands B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraabdominal use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Docetaxel Sandoz
D.2.1.1.2	Name of the Marketing Authorisation holder	Sandoz
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraabdominal use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Gastric cancer with peritoneal carcinomatosis or tumour positive cytology

Maagkanker met peritoneale metastasen of tumorpositieve peritoneale cytologie

E.1.1.1

Medical condition in easily understood language

Gastric cancer with peritoneal metastasis or tumour cells in the abdominal fluid

Maagkanker met buikvliesmetastasen of kankercellen in het buikvocht

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10017812
E.1.2	Term	Gastric neoplasms malignant
E.1.2	System Organ Class	100000004856

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10057647
E.1.2	Term	Cytoreductive surgery
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061269
E.1.2	Term	Malignant peritoneal neoplasm
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061965
E.1.2	Term	Gastrectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10067093
E.1.2	Term	Intraperitoneal hyperthermic chemotherapy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10052171
E.1.2	Term	Peritoneal carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Doel van de studie is om te bepalen of een operatie bestaande uit een maagresectie, cytoreductie en HIPEC bij maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie de overleving verbetert in vergelijking met de huidige standaard behandeling (palliatieve systemische chemotherapie).

E.2.2

Secondary objectives of the trial

- 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.
- 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.
- 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.
- To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional)

- Het vergelijken van progressie-vrije overleving tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie.
- Het bestuderen van de toxiciteit na een behandeling met maagresectie, cytoreductieve chirurgie en HIPEC.
- Het vergelijken van behandelkosten en gezondheidswinst tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie.
- Het identificeren van genetische profielen die gerelateerd zijn aan tumorrespons

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age ≥ 18 years
- cT3-cT4 adenocarcinoma of the stomach, considered to be resectable
- Limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy)
- Absence of disease progression during prior systemic treatment

- Leeftijd > 18 jaar
- Potentieel resectabel cT3-cT4 adenocarcinoom van de maag
- Beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie (vastgelegd d.m.v. een laparoscopie of laparotomie)
- Geen ziekteprogressie tijdens systemische chemotherapie (gegeven voorafgaand aan inclusie)

E.4

Principal exclusion criteria

- Distant metastases 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)
- WHO performance status 3-4
- Inadequate bone marrow, hepatic and renal function
- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- Recent myocardial infarction (< 6 months) or unstable angina
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

- Afstandsmetastasen of peritoneale metastasering op de dunne darm
- Recidief maagcarcinoom
- Eerdere resectie van het primaire maagcarcinoom
- Niet-synchrone peritonitis carcinomatosa
- Aanwezigheid van een andere maligniteit (behalve cervixcarcinoom of basaalcelcarcinoom)
- WHO performance status 3-4
- Onvoldoende beenmerg-, lever- of nierfunctie
- Hepatitis B of C, HIV-infectie of een ongecontroleerde infectie ziekte
- Recent myocard infarct (< 6 maanden) of instabiele angina pectoris
- Ongecontroleerde diabetes mellitus
- Zwangerschap en/of het geven van borstvoeding
- Iedere medische aandoening waarvan te verwachten is dat deze interfereert met de studieprocedures of een veilig behandeltraject
- Bekende overgevoeligheid voor één van de gebruikte chemotherapeutica en/of oplosmiddelen

E.5 End points

E.5.1

Primary end point(s)

Overall survival

Overleving

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall survival will be calculated when 80 deaths are observed.

De overleving wordt berekend na het overlijden van 80 patiënten.

E.5.2

Secondary end point(s)

- Progression free survival
- Treatment-related toxicity
- Costs and resource use
- Quality of life, utilities
- Genetic profiles related to tumour response (optional)

- Progressie-vrije overleving
- Aan de behandeling gerelateerde toxiciteit
- Kosten van de behandeling en de benodigdheden
- Kwaliteit van leven
- Genetische profielen gerelateerd aan de tumorrespons (optie)

E.5.2.1

Timepoint(s) of evaluation of this end point

4 years

4 jaar

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception