Clinical Trials Register

Summary
EudraCT Number:	2013-000138-37
Sponsor's Protocol Code Number:	PERISCOPE
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:	2013-07-01
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

2013-000138-37

A.3

Full title of the trial

Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy

Behandeling van peritoneale uitzaaiingen in maagkanker patienten met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie

A.3.1

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

Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy

Behandeling van peritoneale uitzaaiingen in maagkanker patienten met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie

A.3.2

Name or abbreviated title of the trial where available

PERISCOPE-study

PERISCOPE-studie

A.4.1

Sponsor's protocol code number

PERISCOPE

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	NKI-AvL
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	St. Antonius Ziekenhuis
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	+312051 27 496
B.5.5	Fax number	+312051 22 679
B.5.6	E-mail	trial@nki.nl

D. IMP Identification
D.IMP: 1
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	Eloxatin
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis
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	Intraperitoneal use Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
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 for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraabdominal use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Docetaxel
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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: 3
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	Capecitabine CF
D.2.1.1.2	Name of the Marketing Authorisation holder	Centrafarm 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	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Capecitabine
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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: 4
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	Herceptin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Nederland bv
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	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.4	EV Substance Code	SUB12612MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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 positive peritoneal cytology.

Maagkanker met peritoneale metastasen of positieve peritoneale cytologie

E.1.1.1

Medical condition in easily understood language

Gastric cancer with metastasis located in the peritoneum or tumorcellen located 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	16.0
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	16.0
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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to study the safety, tolerability and feasibility of gastrectomy combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) after neoadjuvant systemic chemotherapy as primary treatment option for advanced gastric cancer with tumour positive peritoneal cytology (C+) and/or limited peritoneal carcinomatosis (P+).

Om de veiligheid, verdraagbaarheid en de haalbaarheid van gastrectomie gecombineerd met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie (HIPEC) na neoadjuvante systemische chemotherapie als primaire behandelingsoptie voor gevorderde maagkanker met tumor positieve peritoneale cytologie (C+) en / of een beperkte peritoneale metastasen (P+) te onderzoeken.

E.2.2

Secondary objectives of the trial

-to determine the maximum tolerated dose of intraperitoneal docetaxel in combination with a fixed dose regimen of intraperitoneal oxaliplatin in gastric cancer patients undergoing gastrectomy combined with CRS and HIPEC after neoadjuvant systemic chemotherapy with DOC or T-DOC in case of HER2-positive tumour
-to investigate the pharmacokinetics of HIPEC after gastrectomy and CRS in patients with advanced gastric cancer and peritoneal dissemination
-to study the effect of neoadjuvant systemic chemotherapy on peritoneal dissemination from gastric cancer (peritoneal cancer index before and after neoadjuvant chemotherapy).
-to identify genetic profiles predictive of tumour response in patients with gastric cancer and peritoneal dissemination undergoing gastrectomy combined with CRS and HIPEC.
-to determine the 2-year disease free and overall survival of advanced gastric cancer patients with tumour positive cytology and/or limited peritoneal carcinomatosis treated with CRS and HIPEC.

-De maximale verdraagbare dosis van intraperitoneale docetaxel in combinatie met een vaste dosering van intraperitoneale oxaliplatine bij maagkanker patiënten die een gastrectomie gecombineerd met cytoreductieve chirurgie (CRS) en HIPEC na neoadjuvante systemische chemotherapie met DOC of T-DOC bij HER2-positieve tumor ondergaan.
-Om de farmacokinetiek van HIPEC na gastrectomie en CRS bij patiënten met maagkanker en peritoneale verspreiding te onderzoeken.
-Om het effect van neoadjuvante chemotherapie op peritoneale verspreiding van maagkanker (PCI vóór en na neoadjuvante chemotherapie) te bestuderen.
-De genetische profielen voorspellend voor tumorrespons bij patiënten met maagkanker en peritoneale verspreiding die gastrectomie gecombineerd met CRS en HIPEC ondergaan te identificeren.
-Om de 2-jaar ziektevrije en algehele overleving van maagkanker patiënten met een tumor positieve cytologie en/of een beperkte peritoneale metastasen behandeld met CRS en HIPEC te bepalen.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection and not a resection of the oesophagus and cardia)
• T3-T4 tumour based upon CT-scan and/or EUS results
• Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy
• Age ≥ 18 years
• WHO performance status 0-1
• ASA classification I-III
• Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion:
a. ANC ≥ 1.5 x 10^9 /L
b. Platelet count ≥ 100 x 10^9 /L
c. Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
d. Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula).
• Wildtype for DPD*2A
• Negative pregnancy test (urine/serum) for female patients of childbearing potential
• Life expectancy ≥ 3 months allowing adequate follow up
• Able and willing to undergo blood sampling for pharmacokinetics
• Written informed consent

• biopsie bewezen adenocarcinoom van de maag (waaronder tumoren op de oesophagogastric overgang op voorwaarde dat het merendeel van de tumor in de maag gelegen is en een maagresectie wordt uitgevoerd en niet een resectie van de slokdarm en cardia)
• T3-T4 tumor op basis van CT-scan en / of EUS resultaten
• Tumor positieve peritoneale cytologie en / of peritoneale metastasen beperkt tot de bovenste buikholte (boven de colon transversum) en / of hoogstens op een locatie in de onderste buikholte (bijvoorbeeld Douglas pouch, ovariale metastase, zuster Mary Joseph nodule) bevestigd door diagnostische laparoscopie
• Leeftijd ≥ 18 jaar
• WHO performance status 0-1
• ASA classificatie I-III
• Adequate beenmerg-, lever- en nierfunctie, minimaal acceptabele laboratoriumwaarden bij aanvang van inclusie:
a. ANC ≥ 1,5 x 10^9 / L
b. Trombocyten ≥ 100 x 10^9 / L
c. Serum bilirubine ≤ 1,5 x ULN, en ALAT en ASAT ≤ 2,5 x ULN
d. Creatinineklaring ≥ 50 ml / min (gemeten of berekend door de Cockcroft-Gault formule).
• Wildtype voor DPD * 2A
• Negatieve zwangerschapstest (urine / serum) voor vrouwelijke patiënten die zwanger kunnen worden
• De levensverwachting ≥ 3 maanden waardoor adequate follow-up
• In staat en bereid om bloedafname voor farmacokinetiek ondergaan
• Schriftelijke informed consent

E.4

Principal exclusion criteria

• Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
• Signs of local irresectability
• Recurrent gastric cancer
• Metachronous peritoneal carcinomatosis
• Prior treatment of gastric cancer with systemic anticancer therapy
• Pregnancy, breast feeding or active pregnancy ambition
• Unreliable contraceptive methods. Patients enrolled in this trial must agree to use a reliable contraceptive method throughout the study
• Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type
• A known history of hepatitis B or C with active viral replication
• Recent myocardial infarction (< 6 months) or unstable angina.
• Uncontrolled diabetes mellitus
• Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment
• Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

• Afstandsmetastasen (bv., lever-, long-, para-aortale lymfeklieren) of verspreiding dunne darm
• Tekenen van lokale irresectabiliteit
• Terugkerende maagkanker
• Metachrone peritoneale carcinomatosis
• Voor de behandeling van maagkanker met systemische therapie tegen kanker
• Zwangerschap, borstvoeding of actieve zwangerschap ambitie
• Onbetrouwbare anticonceptie. Patiënten die deelnemen aan deze studie moeten akkoord gaan met een betrouwbare anticonceptiemethode gedurende de studie
• Ongecontroleerde infectieziekte of bekende Human Immunodeficiency Virus HIV-1 of HIV-2 Type
• Een bekende geschiedenis van hepatitis B of C met actieve virale replicatie
• Recent myocardinfarct (<6 maanden) of onstabiele angina.
• Ongecontroleerde diabetes mellitus
• Elke medische conditie nog niet boven gespecificeerd, die wordt beschouwd als mogelijk, waarschijnlijk of beslist verstorend voor deelname aan de studie procedures, met inbegrip van een adequate follow-up en / of wil veilige behandeling in gevaar brengen
• Bekende overgevoeligheid voor een van de toegepaste chemotherapeutische middelen en / of de oplosmiddelen

E.5 End points

E.5.1

Primary end point(s)

Treatment related toxicity (graded according to the NCI Common Toxicity Criteria version 4.0)

Behandeling gerelateerde toxiciteit (beoordeeld door middel van de NCI Common Toxicity Criteria versie 4.0)

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 dagen

E.5.2

Secondary end point(s)

- postoperative morbidity and mortality
- completion of the study protocol
- pharmacokinetic parameters (systemic, intraperitoneal fluid concentrations of oxaliplatin and docetaxel)
- cytoreductive completeness score
- patterns of tumour recurrence
- disease free and overall survival

- Postoperatieve morbiditeit en mortaliteit
- Afronding van het studie protocol
- Farmacokinetische parameters (systemisch en intraperitoneaal vocht van oxaliplatin en docetaxel)
- Cytoreductieve compleetheidsscore
- Patronen terugkeer van de ziekte
- Ziektevrije en totale overleving

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years

2 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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Dose-escalation trial

dosis-escalatie studie

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

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)

E.8.2.2

Placebo

E.8.2.3

Other

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)

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Normal treatment and follow-up according to national guidelines of follow-up after gastric cancer treatment.

Normale behandeling en follow-up volgens de nationale richtlijnen van follow-up na maagkanker behandeling.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-07-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-25

P. End of Trial
P.	End of Trial Status	Ongoing

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Clinical trials