Clinical Trials Register

Summary
EudraCT Number:	2012-000437-39
Sponsor's Protocol Code Number:	M211ART
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-13
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

Spain - AEMPS

A.2

EudraCT number

2012-000437-39

A.3

Full title of the trial

ARTFORCE - Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE.
A randomised study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer

ARTFORCE - Tratamiento radioterápico adaptativo e innovador para mejorar el resultado del tratamiento del cáncer.
Estudio aleatorizado con cisplatino o cetuximab y radioterapia estandar o adaptativa a alta dosis en cáncer localmente avanzado de cabeza y cuello

A.3.1

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

A randomised study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer

Estudio aleatorizado con cisplatino o cetuximab y radioterapia estandar o adaptativa a alta dosis en cáncer localmente avanzado de cabeza y cuello

A.3.2

Name or abbreviated title of the trial where available

ARTFORCE

A.4.1

Sponsor's protocol code number

M211ART

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	Stichting Antoni van Leeuwenhoek Ziekenhuis
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	Stichting Antoni van Leeuwenhoek 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	Dr. Jordi Giralt
B.5.2	Functional name of contact point	Dr. Jordi Giralt
B.5.3	Address:
B.5.3.1	Street Address	Paseo Vall d'Hebron 119-129
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	349327461256086
B.5.5	Fax number	34934894102
B.5.6	E-mail	jgiralt@vhebron.net

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	Erbitux
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck KGaA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	CETUXIMAB
D.3.9.1	CAS number	205923-56-4
D.3.9.4	EV Substance Code	SUB01178MIG
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	2
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	Yes
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	Comparator
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	Cisplatino Ferrer Farma
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRER FARMA, S. A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	cisplatinum
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	CISPLATIN
D.3.9.1	CAS number	15663-27-1
D.3.9.4	EV Substance Code	SUB07483MIG
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

Explore the impact of pre-treatment information and dose redistribution on locoregional control in patients with locally advanced SCCHN.

ARREGLAR

Explora el impacto de pre-tratamiento de la información y la redistribución de la dosis en el control locorregional en los pacientes con CECC localmente avanzado.

ARREGLAR

E.1.1.1

Medical condition in easily understood language

Explore the impact of pre-treatment information and dose redistribution on locoregional control in patients with locally advanced SCCHN.

ARREGLAR

Explora el impacto de pre-tratamiento de la información y la redistribución de la dosis en el control locorregional en los pacientes con CECC localmente avanzado.

ARREGLAR

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 determine the effect and toxicity of concomitant chemoradiation or Cetuximab with standard dose distribution versus concomitant chemoradiation or Cetuximab with adaptive inhomogeneous dose distribution (redistribution) on locoregional progression free survival.

Determinar el efecto y la toxicidad de la quimiorradioterapia concomitante o cetuximab con distribución de la dosis estándar versus quimiorradioterapia concomitante o cetuximab con una distribución adaptativa de la dosis no homogénea (redistribución) en la supervivencia libre de progresión locorregional.

E.2.2

Secondary objectives of the trial

Zr89-Cetuximab uptake (on FDG-PET) predicts treatment-specific outcome.

La absorción de Cetuximab-Zr89 (en el FDG-PET) predice el resultado del tratamiento específico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Stage III-IV, T3-4, SCC Head and Neck, <70 years, GFR >60, Performance status: WHO 0-1

Estadio III-IV; T3-4; Carcinoma escamoso de cabeza y cuello; <70 años; Tasa de Filtración Glomerular >60; Estado general OMS 0-1

E.4

Principal exclusion criteria

Inability to receive one of the treatment arms, laryngeal cancer, known active symptomatic infections, prior surgery, radiotherapy or chemotherapy for this tumor

Incapacidad para recibir uno de los brazos de tratamiento; Cáncer de laringe; Infecciones sintomáticas activas conocidas; Tratamiento quirúrgico, radioterápico o quimioterápico previo para este tumor.

E.5 End points

E.5.1

Primary end point(s)

1. Locoregional recurrence-free survival at 2 years.
2. Correlation of anatomical distribution of ZR89-cetuximab uptake with treatment arm and anatomical location of recurrence
3. Toxicity
Interim analysis on safety planned after 100 patients.

1. Supervivencia libre de recidiva locorregional a los 2 años.
2. Correlación entre la distribución anatómica de la captación de Cetuximab-ZR89 con el brazo de tratamiento y la localización anatómica de la recaida local
3. Toxicidad
Análisis provisional sobre la seguridad previsto después de 100 pacientes.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years

2 años

E.5.2

Secondary end point(s)

1. Quality of life during and after treatment, at 6 months and 1 yr.
2. Swallowing function preservation at 1 yr.
3. Progression-free survival, overall survival, toxicity.

1. Calidad de vida durante y después del tratamiento, a los 6 meses y 1 año.
2. Preservación de la deglución al año.
3. Supervivencia libre de progresión, supervivencia global, toxicidad.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 and 12 months

6 y 12 meses

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Prediction?????

Predicción?????

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

The last visit of the last subject undergoing the trial

La última visita del paciente

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

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:

200

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

268

F.4.2.2

In the whole clinical trial

268

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)

Is not different from the expected normal treatment of that condition

No es diferente

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

2012-10-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-23

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

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