Clinical Trial Page

Summary
EudraCT Number:2004-004707-38
Sponsor's Protocol Code Number:RMH CCR: 2553
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:2006-01-19
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-004707-38
A.3Full title of the trial
Ensayo clínico multicéntrico, aleatorizado de fase II, de comparación de oxaliplatino (Eloxatin), capecitabina (Xeloda) y radioterapia preoperatoria con o sin cetuximab, seguidos de la excisión total del mesorrecto (ETM) como tratamiento de pacientes con cáncer rectal de alto riesgo definido por resonancia magnética (RM).
A.3.2Name or abbreviated title of the trial where available
EXPERT-C
A.4.1Sponsor's protocol code numberRMH CCR: 2553
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorProf David Cunningham
B.1.3.4CountryUnited Kingdom
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Erbitux
D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameErbitux
D.3.2Product code EMD271786
D.3.4Pharmaceutical form Intravenous infusion
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNCetuximab
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typenot less then
D.3.10.3Concentration number2
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typeAnticuerpo Monoclonal
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Eloxatin
D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameEloxatin
D.3.4Pharmaceutical form Powder for solution for infusion
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNOxaliplatino
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 3
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Xeloda
D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameXeloda
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNCapecitabine
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number150 o 500
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another 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.1.1Medical condition(s) being investigated
Cáncer rectal de alto riesgo definido por resonancia magnética.
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluar la mejoría de la tasa de respuesta completa patológica derivada de la adición del cetuximab a la quimioterapia neoadyuvante con oxaliplatino y capecitabina, seguidos de quimiorradioterapia sincrónica y excisión total de mesorrecto en pacientes con cáncer rectal de alto riesgo definido por resonancia magnética (RM).
E.2.2Secondary objectives of the trial
- Tasas de respuesta radiológica después de la quimioterapia neoadyuvante y después de la finalización de toda quimioterapia neoadyuvante.
- Tasa de resección completa (resección R0) con margen de resección libre de tumor al microscopio (Tumor observado >1mm del margen de resección ), especialmente del margen de resección circunferencial.
- Mediciones perioperatorias y mortalidad durante los 30 días posteriores a la evaluación
- Complicaciones postoperatorias como infección de la herida, dehiscencia de la herida, formación de fístulas
- Calidad de la excisión total del mesorrecto
- Tasa de amputación abdominoperineal, de colostomías de protección permanentes y de fugas anastomóticas clínicas y radiológicas
- Supervivencia libre de progresión y Supervivencia global
- Seguridad y Calidad de vida
- Evaluación de los factores predictivos moleculares y genéticos de respuesta
- Evaluación de los cambios de expresión génica que se producen como respuesta al tratamiento.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
- Edad ≥ 18 años.
- Diagnóstico histológico de adenocarcinoma o carcinoma no microcítico indiferenciado de recto.
- Cáncer rectal de alto riesgo operable, definido como tal por la presencia en la RM de al menos uno de los siguientes hallazgos:
1) Tumores ≤1 mm de la fascia mesorrectal, es decir, sospecha o afectación del margen de resección circunferencial
2) Tumores T3 en los músculos elevadores o debajo de éstos
3) Tumores que se extienden ≥ 5 mm en la grasa perirrectal
4) Tumores T4 (incluida la afectación de la vejiga urinaria o vagina si la resección quirúrgica es posible con márgenes libres de tumor)
5) Presencia de invasión venosa extramural (por tanto, el tumor primario es como mínimo T3)

- Estado funcional de la OMS de 0-2.
- Sin indicios de enfermedad metastásica determinada a partir de las imágenes de TAC torácico y abdominal u otras exploraciones como tomografía por emisión de positrones (TEP) o biopsia si procede.
- Función medular adecuada con plaquetas > 100 x 109/l; leucocitos > 3 x 109/l; neutrófilos > 1,5 x 109/l.
- Bilirrubina sérica < 1,5 límite superior del intervalo normal (LSN) y transaminasas < 2,5 x LSN
- Creatinina sérica inferior al LSN o aclaramiento calculado de creatinina > 50 ml/min
- Sin ninguna afección médica concurrente no controlada.
- Sin enfermedad maligna activa excepto cáncer cutáneo no melanótico o carcinoma in situ del cuello del útero en los últimos 10 años.
- Esperanza de vida > 3 meses.
- Medios anticonceptivos adecuados si procede.
- Consentimiento informado por escrito.
E.4Principal exclusion criteria
- Cualquier contraindicación para la realización de la RM (pacientes con marcapasos, etc.)
- Enfermedades médicas o psiquiátricas que puedan comprometer la capacidad del paciente para otorgar su consentimiento informado.
- Los pacientes con cáncer de recto que se considere inoperable en el momento del diagnóstico no podrán ser incluidos incluso en el supuesto de que pudieran serlo si el tumor primario sufriera una reducción de la estadificación gracias al tratamiento neoadyuvante. Ello incluye a los pacientes con enfermedad inoperable localmente avanzada, como la diseminación del tumor más allá de la fascia mesorrectal en las estructuras de la pared lateral de la pelvis, o situaciones en las que la resección quirúrgica con márgenes libres de tumor resulte improbable.
- Cáncer rectal T1-2 a cualquier nivel.
- Presencia de enfermedad metastásica o tumor rectal recurrente.
- Enfermedades clínicas no controladas y concurrentes.
- Quimioterapia o radioterapia previas, o un tratamiento experimental para el cáncer de recto.
- Embarazo o lactancia.
- Los pacientes con síndromes de malabsorción conocidos o falta de integridad física del tubo digestivo superior.
- Enfermedad cardíaca clínicamente significativa (activa) (p. ej. insuficiencia cardíaca congestiva, coronariopatia sintomática y arritmia cardíaca como p. ej. fibrilación auricular, aunque esté controlada con medicación) o infarto de miocardio en los últimos 12 meses.
- Pacientes con síntomas o antecedentes de neuropatía periférica.
E.5 End points
E.5.1Primary end point(s)
Tasa de respuesta completa patológica a la excisión total del mesorrecto.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Yes
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial 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
El final del ensayo se define como el momento en el que todos los pacientes han realizado la primera visita de seguimiento después de la visita de final del estudio.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years7
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years7
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state40
F.4.2 For a multinational trial
F.4.2.1In the EEA 164
F.4.2.2In the whole clinical trial 164
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)
El manejo clínico estándar aplica. A los pacientes que no sufran una recaída se les realizará seguimiento hasta los 5 años tras fin de tratamiento antes de ser discontinuados y después, según el manejo clínico que corresponde de acuerdo con la enfermedad en estudio
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-01-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-12-12
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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