Clinical Trials Register

Summary
EudraCT Number:	2013-001028-21
Sponsor's Protocol Code Number:	ABCSG_P01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-04-12
Trial results	View 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2013-001028-21

A.3

Full title of the trial

P01 - A prospective, randomized, multicenter trial of additional radiochemotherapy to neoadjuvant chemotherapy in patients with locally advanced pancreatic adenocarcinoma

P01 - Prospektive, randomisierte, multizentrische Studie über den Stellenwert zusätzlicher Strahlenchemotherapie zur neoadjuvanten Chemotherapie in PatientInnen mit lokal fortgeschrittenem Bauchspeicheldrüsenkrebs

A.3.1

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

P01 - A prospective, randomized, multicenter trial of additional radiochemotherapy to neoadjuvant chemotherapy in patients with locally advanced pancreatic adenocarcinoma

A.4.1

Sponsor's protocol code number

ABCSG_P01

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	ABCSG (Austrian Breast & Colorectal Cancer Study Group)
B.1.3.4	Country	Austria
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	ABCSG
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ABCSG /Austrian Breast & Colorectal Cancer Study Group)
B.5.2	Functional name of contact point	Trial Office
B.5.3	Address:
B.5.3.1	Street Address	Nussdorfer Platz 8
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1190
B.5.3.4	Country	Austria
B.5.4	Telephone number	+4314089230
B.5.6	E-mail	info@abcsg.at

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.2.5	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.3.1	Product name	Gemcitabine
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	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.4	EV Substance Code	SUB07892MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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.2.5	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.3.1	Product name	Oxaliplatin
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	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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

locally advanced pancreatic adenocarcinoma

E.1.1.1

Medical condition in easily understood language

locally advanced pancreatic adenocarcinoma

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10051971
E.1.2	Term	Pancreatic adenocarcinoma
E.1.2	System Organ Class	100000004864

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 demonstrate that in patients suffering from locally advanced PDAC, the addition of radiochemotherapy to standard neoadjuvant chemotherapy is superior to chemotherapy alone with respect to R0 resection rate.

E.2.2

Secondary objectives of the trial

To demonstrate superior efficacy of radiochemotherapy to neoadjuvant chemotherapy with respect to
• Tumor response according to RECIST criteria
• Progression- (PFS) and/or disease-free survival (DFS) and overall survival (OS)
• Toxicity according to NCI CTCAE v.4.0
• Perioperative complications
• Radiochemotherapy quality assurance (adherence to protocol)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients with histologically proven PDAC, classified as locally advanced disease, borderline resectable, if one or more of the following criteria are detectable:
o Tumor-associated deformity of the superior mesenteric vein (SMV) or portal vein (PV)
o Abutment of the SMV or PV ≥ 180°
o Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction
o Short-segment involvement of the hepatic artery (HA) or its branches amenable to resection and reconstruction
o Abutment of the superior mesenteric artery (SMA) ≤180°
• Patients scheduled for neoadjuvant treatment by the interdisciplinary tumour board
• Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to randomization
• Patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study
• ECOG performance status ≤1 (see Appendix 4) or Karnofsky ≥70%
• Adequate hematologic function, as follows (≤ 28 d prior to randomization):
o absolute neutrophil count (ANC) ≥ 1.5 x 109/L (in case ANC is not routinely measured, as alternative relative neutrophil count > 50% is acceptable)
o leucocyte count≥3.0 x 109/L
o platelet count ≥ 100 x 109/L
o haemoglobin ≥ 9 x g/dL
• Adequate renal function, as follows (≤ 28 d prior to randomization):
o creatinine ≤ 1.5 x upper limit of normal (ULN)
• Adequate hepatic function, as follows (≤ 28 d prior to randomization):
o aspartate aminotransferase (ASAT) ≤ 5 x ULN
o alanine aminotransferase (ALAT) ≤ 5 x ULN
o total bilirubin ≤ 2.5 x ULN
• Any age ≥ 18-80 years
• Life expectancy > 6 months
• Informed consent signed prior to randomization and prior to any study specific procedure
• Ability to comply with the protocol and attend follow up
• Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to study drug administration. Patients are not considered of childbearing potential:
o after having undergone hysterectomy and/or bilateral ovarectomy
o ≥ 60 years
o with FSH and E2 in the postmenopausal range

E.4

Principal exclusion criteria

• Major surgery within 4 weeks prior start of study treatment
• Any past or current history of other malignancies less than 2 years prior to randomization
• Any radiological suspicion, or histological proof of distant metastases or extra-pancreatic disease other than regional lymph node enlargement at initial staging
• Any chemo- or radiotherapy for PDCA prior to study inclusion
• Concurrent or prior systemic antitumor therapy within the last 2 years
• Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to randomization
• Concurrent administration of IMP during treatment phase; planned participation in P00 will not be considered as an exclusion criterion
• Concurrent participation in another clinical trial with the same primary endpoint
• Pregnancy, lactation, patients (and patients with partner fulfilling the following criteria) of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment
• Previous irradiation within the actual fields of planned radiotherapy
• Any known hypersensitivity/allergic reaction to any of the components of study treatments
• Any severe and/or uncontrolled medical conditions including but not limited to:
o Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia
o Acute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
o Active skin, mucosa, ocular or GI disorders of Grade > 1
o Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study

E.5 End points

E.5.1

Primary end point(s)

Histological R0 resection rate in the intention to treat group.

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation after neoadjuvant treatment and surgery.

E.5.2

Secondary end point(s)

• Tumor response measured by RECIST criteria
• Histo-pathological tumor response with respect to proportion of severely degenerative cancer cells
• DFS as time from surgery to PDAC recurrence in R0 patients
• PFS as time from randomization until disease progression
• OS as time from randomization to death from any cause
• occurrence of treatment related toxicities
• perioperative complications classified according to Clavien and Dindo (see appendix 8)
• total duration and interruptions of radiochemotherapy, total dose of the radiotherapy and administration of concomitant chemotherapy during radiotherapy

E.5.2.1

Timepoint(s) of evaluation of this end point

• Tumor response, histo-pathological tumor response, perioperative complications: Evaluation after neoadjuvant treatment and surgery.
• DFS, PFS and OS: Evaluation after last patient had the last follow-up visit

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

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)

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

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Radiochemotherapy

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

the end of trial is defined with database closure

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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)

standard after care outside the protocol

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

2013-05-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-03-12

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials