Clinical Trials Register

Summary
EudraCT Number:	2014-004678-41
Sponsor's Protocol Code Number:	UC_0160/1406
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-02-23
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

France - ANSM

A.2

EudraCT number

2014-004678-41

A.3

Full title of the trial

Etude prospective de phase II d’évaluation d’une prise en charge multimodale des métastases ganglionnaires inguinales des carcinomes épidermoïdes du pénis par lymphadénectomie bilatérale et chimiothérapie TIP (paclitaxel, ifosfamide et cisplatine).

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

AFU-GETUG 25 - MEGACEP

A.4.1

Sponsor's protocol code number

UC_0160/1406

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	UNICANCER
B.1.3.4	Country	France
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	Institutionels
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UNICANCER
B.5.2	Functional name of contact point	Muriel HABIBIAN
B.5.3	Address:
B.5.3.1	Street Address	101, rue de Tolbiac
B.5.3.2	Town/ city	Paris cedex 13
B.5.3.3	Post code	75654
B.5.3.4	Country	France
B.5.4	Telephone number	+33176 64 78 07
B.5.5	Fax number	+33185 34 33 79
B.5.6	E-mail	m-habiban@unicancer.fr

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	PACLITAXEL
D.2.1.1.2	Name of the Marketing Authorisation holder	ARROW GENERIQUES
D.2.1.2	Country which granted the Marketing Authorisation	France
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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
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	IFOSFAMIDE
D.2.1.1.2	Name of the Marketing Authorisation holder	EG LABO - Laboratoires EuroGenerics
D.2.1.2	Country which granted the Marketing Authorisation	France
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	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	IFOSFAMIDE
D.3.9.1	CAS number	3778-73-2
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	CISPLATINE
D.2.1.1.2	Name of the Marketing Authorisation holder	MYLAN SAS
D.2.1.2	Country which granted the Marketing Authorisation	France
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	CISPLATINE
D.3.9.1	CAS number	15663-27-1
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
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	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

Tumeur du pénis

E.1.1.1

Medical condition in easily understood language

Tumeur du pénis

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10062064
E.1.2	Term	Penis carcinoma
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

Evaluation du taux de survie sans récidive ganglionnaire locorégionale (inguinale et iliaque) chez des patients atteint d’un carcinome épidermoïde du pénis pN+ présentant des métastases ganglionnaires inguinales après un traitement associant une chimiothérapie TIP adjuvante ou néoadjuvante au curage ganglionnaire inguinal.

E.2.2

Secondary objectives of the trial

• Evaluation du taux de réponses complètes à la chimiothérapie (stérilisation tumorale) à 24 mois pour les patients traités par chimiothérapie néo-adjuvante
• Evaluation du taux de récidives métastatiques à 3 ans
• Evaluation du taux de survie globale spécifique à 3 ans
• Evaluation du taux de survie globale à 3 ans
• Evaluation de la toxicité de la chimiothérapie

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

• Intérêt de la surveillance par dosage sanguin du SCC (Squamous Cell Carcinoma) et du Cyfra-21.
• Recherche de marqueurs tissulaires pronostiques de la réponse au traitement et de la survie globale.
• Intérêt et de la fiabilité du PET-scan pour le bilan d’extension ganglionnaire évaluées par la sensibilité et la spécificité du PET-scan.

E.3

Principal inclusion criteria

1. Tumeur du pénis histologiquement prouvée quel que soit le traitement initial de la tumeur pénienne : chirurgie conservatrice ou amputation ou curiethérapie,
2. Une ou des adénopathies palpées et mobiles (stade cN1 et cN2) et quel que soit le stade T,
Ou
si pas d'adénopathie inguinale palpée (cN0), tumeur à risque d'envahissement ganglionnaire ≥pT1b et / ou Grade 2,
3. Atteinte ganglionnaire métastatique
4. Patients M0 ou Mx (par imagerie),
5. Age≥ ou >18 ans,
6. ECOG 0-1,
7. Leucocytes ≥ 1.5 G/L,
8. Hémoglobine ≥ 9 g/dL,
9. Plaquettes ≥100 000/mm3,
10. Calcémie et kaliémie normales,
11. Fonction hépatique : ASAT et ALAT ≤ 1.5 LNS ; bilirubine totale ≤ 1.5 LNS (≤ 3 x LNS en cas de maladie de Gilbert); PAL < 2 LNS,
12. Fonction rénale : Clairance de la créatinine ≥ 60 mL/mn (calculée par la méthode MDRD),
13. FEVG > 50%,
14. Patients ayant reçu et lu la note d’information et signé le consentement,
15. Patients en âge de procréer acceptants d’utiliser deux méthodes de contraception (une pour le patient et une pour la partenaire) pendant toute la durée de l’étude et pendant 6 mois après la dernière administration du traitement,
16. Patients capables de se conformer aux exigences du protocole (visites prévues, plan de traitement, examens cliniques, paracliniques et biologiques et toutes autres procédures prévues au protocole),
17. Patients bénéficiant d’un régime de sécurité sociale.

E.4

Principal exclusion criteria

1. Une ou des adénopathies inguinales fixées (patients cN3)
2. Une ou des adénopathies iliaques (y compris par imagerie) (patients cN3)
3. Patients pN3
4. Chimiothérapie antérieure pour le carcinome épidermoïde du pénis,
5. Contre-indication à la chimiothérapie ou hypersensibilité connue au cisplatine, à l’ifosfamide ou au paclitaxel,
6. Patients traités par phénytoïne,
7. Patients présentant une pathologie cardio-respiratoire contre-indiquant l’hyperhydratation,
8. Antécédents de cancer dans les 5 ans précédant l’inclusion dans l’essai autre qu’un baso-cellulaire cutané,
9. Patient ayant reçu un vaccin vivant atténué dans les 30 jours précédant l’inclusion,
10. Patients déjà inclus dans un autre essai thérapeutique ou ayant reçu un traitement expérimental dans les 30 jours précédant l’inclusion dans l’essai,
11. Patients privés de leur liberté ou sous protection judiciaire y compris sous tutelle,
12. Toute évidence, selon l’investigateur, d’une maladie systémique sévère ou non contrôlée ou toute autre maladie chronique ou aigue qui serait incompatible avec la participation du patient à cet essai,
13. Patients immunodéficients y compris avec une séropositivité connue pour le virus de l'immunodéficience humaine (VIH),
14. Patients présentant une altération mentale qui empêcherait la compréhension du protocole ou présentant un état psychologique, des conditions familiales, sociologiques ou géographiques qui ne permettraient pas la compliance au protocole et au suivi prévu ou toute condition qui, selon l’investigateur, empêcherait la participation du patient à l’essai. Ces conditions doivent être évaluées avant l’inclusion des patients.

E.5 End points

E.5.1

Primary end point(s)

Taux de survie sans récidive ganglionnaire locorégionale à 24 mois évaluée par échographie inguinale.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

• Taux de réponse complète définie par une absence de tumeur résiduelle (stérilisation tumorale) sur la pièce du curage ganglionnaire après la chimiothérapie néo-adjuvante en cas de cytoponction ganglionnaire positive avant la chimiothérapie
• MFS à 3 ans
• OS spécifique à 3 ans
• Survie globale à 3 ans
• Taux de toxicité de la chimiothérapie sera évaluée selon les CTC-AE V4.03

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

Yes

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

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)

NONE

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

2016-01-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-01-05

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

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