Clinical Trials Register

Summary
EudraCT Number:	2007-004917-33
Sponsor's Protocol Code Number:	2007-004917-33
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:	2008-05-06
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

2007-004917-33

A.3

Full title of the trial

Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.

Studio randomizzato di fase III che confronta chemioradioterapia concomitante e chemioterapia adiuvante con radioterapia pelvica esclusiva nel carcinoma endometriale ad alto rischio e in fase avanzata

A.3.2

Name or abbreviated title of the trial where available

PORTEC-3

A.4.1

Sponsor's protocol code number

2007-004917-33

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN14387080

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	IST. DI RICERCHE FARMACOLOG. M. NEGRI
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.2.1.2	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	Concentrate 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	cisplatin
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	50
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

High risk and advanced stage endometrial carcinoma

Carcinoma dell'endometrio ad alto rischio di recidiva o avanzato

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	10014759
E.1.2	Term	Endometrial neoplasm
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 objective of this study is to establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone

sopravvivenza globale e libera da recidiva per pazienti con carcinoma dell endometrio ad alto rischio e in fase avanzata, trattate dopo chirurgia con radioterapia e chemioterapia concomitante ed adiuvante in confronto a pazienti trattate con sola radioterapia pelvica

E.2.2

Secondary objectives of the trial

Secondary objectives are to establish and compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life.

tossicita' correlata al trattamento,qualita' della vita,recidive pelviche e a distanza

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

LIFE QUALITY:
Vers:
Date:
Title:
Objectives:

QUALITA DELLA VITA:
Vers:
Data:
Titolo:
Obiettivi:

E.3

Principal inclusion criteria

Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO stages (confirmed at pathology review, see section 8.1): a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI) b. Stage IC grade 3 c. Stage II (occult) grade 3 d. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3 e. Stage IB, IC, II or III with serous or clear cell histology 2. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingooophorectomy). However, for a patient who has had lymphadenectomy and/or full surgical staging, and was found after PA diagnosis to meet the eligibility criteria, inclusion in the trial is permitted. 3. WHO-performance status 0-2 4. WBC ≥ 3.0 x 109/L. 5. Platelets ≥ 100 x 109/L.

Carcinoma endometrioide confermato istologicamente con una delle seguenti caratteristiche postoperatorie (stadio e grado FIGO) 1. stadio IB G3 con infiltrazione degli spazi linfovascolari 2. stadio IC G3 3. stadio II (occulto) G3 4. stadio IIIA o III C (IIIA per sola citologia solo se G3) 5. stadio IB o IC, II o III con istologia sierosa o a cellule chiare WHO PS 0-2 WBC > 3.0 x 109/l piastrine > 100 x 109/l bilirubina > 1.5 x UNl ASAT/ALAT > 2.5 UNl consenso informato scritto

E.4

Principal exclusion criteria

1. Uterine sarcoma 2. History of any previous malignancy, except for basal cell carcinoma of the skin, within the last 10 years 3. Previous pelvic radiotherapy 4. Hormonal therapy or chemotherapy for this tumor 5. Macroscopic stage IIB for which radical (Wertheim type) hysterectomy has been performed 6. Prior diagnosis of Crohn s disease or ulcerative colitis 7. Residual macroscopic tumor after surgery 8. Impaired renal function: creatinine clearance ≤ 60 ml/min (calculated according to Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance) 9. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy 10. Peripheral Neuropathy > grade 2

pregresse neoplasie maligne negli ultimi 10 anni (escluso il basalioma cutaneo) pregressa radioterapia pelvica terapia ormonale o chemioterapia per questa malattia stadio IIB macroscopico (richiede isterectomia radicale) morbo di Crohn o colite ulcerosa tumore residuo macroscopico dopo chirurgia clearance della creatinina < 60 ml/min (sec. Cockroft) o < 50 ml/min (EDTA clearance, o clearance della creatinina calcolata) insufficienza cardiaca che impedisca adeguata idratazione durante la terapia con platino neuropatia periferica > G2

E.5 End points

E.5.1

Primary end point(s)

Overall survival and failure-free survival

sopravvivenza globale e libera da malattia

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

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)

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

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

chemioradio vs radio

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

Yes

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

endpoint: sopravvivenza a 5 anni con analisi da effettuarsi dopo l'osservazione di 215 eventi

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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	No
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	100
F.4.2	For a multinational trial
F.4.2.1	In the EEA	500
F.4.2.2	In the whole clinical trial	500

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

2008-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-12-05

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

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