Clinical Trials Register

Summary
EudraCT Number:	2007-000557-61
Sponsor's Protocol Code Number:	2/2007/O/Sper
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2007-04-03
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-000557-61

A.3

Full title of the trial

PROSPECTIVE RANDOMIZED STUDY ON NEOADJUVANT
CHEMORADIOTHERAPY PLUS SURGERY VS. SURGERY ALONE IN
PATIENTS WITH RESECTABLE PANCREATIC ADENOCARCINOMA'

'STUDIO PROSPETTICO RANDOMIZZATO SULLA CHEMIORADIOTERAPIA NEOADIUVANTE ASSOCIATA ALLA CHIRURGIA VS. CHIRURGIA NEI PAZIENTI CON ADENOCARCINOMA PANCREATICO RESECABILE'

A.4.1

Sponsor's protocol code number

2/2007/O/Sper

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	AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	GEMZAR*INFUS 1FL 1G POLV
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY ITALIA SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Gemcitabine
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.3	Concentration number	1
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	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

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

PANCREATIC ADENOCARCINOMA'

adenocarcinoma pancreatico

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	PT
E.1.2	Classification code	10052747
E.1.2	Term	Adenocarcinoma pancreas
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

verify the possibility that the rate of potentially curative
surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus
surgery.

Verificare se il tasso di resezioni chirurgiche potenzialmente curative senza residuo di malattia,
ovvero R0 nei pazienti affetti da adenocarcinoma duttale del pancreas resecabile, trattati con
radiochemioterapia neoadiuvante, sia significativamente superiore a quello riscontrato in un
comparabile gruppo di pazienti sottoposti a resezione chirurgica senza trattamento neoadiuvante.
Viene considerato come successo della terapia, un aumento delle resezioni R0 del 30% nei
pazienti resecati sottoposti a terapia neoadiuvante rispetto al gruppo di controllo ovvero pazienti
sottoposti in prima istanza a sola terapia chirurgica.

E.2.2

Secondary objectives of the trial

Safety and efficacy of neoadjuvant chemoradiotherapy

Valutare la tossicita' della terapia neoadiuvante,la differenza tra pazienti sottoposti o meno a
terapia neoadiuvante riguardo allo stadio pTNM della malattia,alla morbilita' ed alla mortalita'
post‐operatoria.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOGENETIC:
Vers:Emen08
Date:2010/12/06
Title:
Objectives:

FARMACOGENETICA:
Vers:Emen08
Data:2010/12/06
Titolo:STUDIO ANCILLARE SUL PROFILO DI ESPRESSIONE GENICA (GENOTYPING) DI PAZIENTI AFFETTI DA ADENOCARCINOMA DEL PANCREAS OPERABILE
Obiettivi:Obiettivo Primario: 1) verificare o meno l’esistenza di differenti pattern molecolari per adenocarcinomi pancreatici non metastatici alla diagnosi e suscettibili di radicalizzazione chirurgica, mediante l’analisi non-supervisionata dei profili di espressione genica (analisi di cluster e analisi delle componenti principali). Obiettivi Secondari: 1) verificare o meno la correlazione di tali profili genici con il diverso andamento clinico dei pazienti sottoposti al medesimo trattamento, sia chirurgico che chemio-radioterapico, mediante l’analisi supervisionata dei profili di espressione genica e di copy number del gruppo dei responder rispetto ai non-responder alla terapia. 2) Identificare i profili genici predittivi della risposta alla terapia, mediante analisi supervisionata di class prediction (utilizzando approcci di machine-learning quali nearest shrunken centroids, support vector machine..) delle due classi di pazienti. Si precisa che i criteri di inclusione ed esclusione al sottostudio sono gli stessi dello studio principale “Studio prospettico randomizzato sulla chemioterapia neoadiuvante associata alla chirurgia vs. chirurgia nei pazienti con adenocarcinoma pancreatico resecabile”

E.3

Principal inclusion criteria

Patients with histological proven pancreatic ductal adenocarcinoma
Patients who have supplied the written informed consent.
Patients who have completed the staging of the disease

Pazienti maschi e femmine, di eta' compresa tra i 18 anni e i 75 anni.
Pazienti con ECOG =0‐1
Pazienti con anamnesi personale negativa per resezioni pancreatiche, o pregresso
adenocarcinoma del pancreas.
Pazienti con funzione epatica, renale, cardiaca, ed ematologica adeguata: in particolare
saranno inclusi nello studio solo pazienti con conta totale dei granulociti neutrofili ≥ 1,5 x
109/l, piastrine ≥ 100 x 109/l; emoglobina ≥ 9,0 g/dl , creatinina sierica ≤ 2,0 mg/dl, albumina ≥
2,5 g/dl; ASAT GOT e/o ALAT GPT ≤ 2,5 x LSN limite superiore di norma; PT tempo di
protrombina e PTT tempo di tromboplastina parziale ≤ 1,5 x LSN.
Classe ASA <4.
Pazienti senza evidenza di infezioni in atto o altre condizioni cliniche che possano
controindicare trattamenti medici e chirurgici e precludere la partecipazione del paziente
allo studio.

E.4

Principal exclusion criteria

Cerebral metastases
HIV infection or AIDS.
Not agreement or withdrawal of the informed consent.
Pregnant women

Chemio e/o radioterapia nei precedenti 6 mesi.
Trattamento con qualsiasi farmaco sperimentale nei 30 giorni precedenti l'arruolamento.
Pazienti con allergia confermata ad uno qualsiasi dei componenti dei farmaci dello studio.
Altre concomitanti patologie neoplastiche diagnosticate negli ultimi 5 anni con l'eccezione
del carcinoma basocellulare e del carcinoma cervicale in situ.
Intervento di chirurgia maggiore, biopsia a cielo aperto, o lesione traumatica significativa
nei 28 giorni precedenti l'inizio del trattamento o previsione della necessita' di un intervento
di chirurgia maggiore durante il corso dello studio.
Qualsiasi condizione che, a giudizio del medico, possa pregiudicare la partecipazione del
soggetto allo studio.
Qualsiasi condizione che possa pregiudicare la capacita' del paziente di fornire il consenso
informato scritto.

E.5 End points

E.5.1

Primary end point(s)

The end point of the study is that to verify the possibility that the rate of potentially curative
surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus
surgery.

L'end point primario di questo studio e' confrontare il tasso di resezioni pancreatiche senza
residuo di malattia (R0) nei pazienti resecati appartenenti ai due bracci.

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

chemio-radioterapia

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

Information not present in EudraCT

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	64

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

2007-02-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-02-06

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

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