| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Locally advanced non small cell lung cancer |
| Cancer de pulmón no microcitico locamente avanzado |
|
| E.1.1.1 | Medical condition in easily understood language |
| Lung Cancer |
| Cáncer de pulmón |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To estimate the effect of CT-RT on pCR in resectable patients |
| Estimar el efecto de la QT-RT en la RCp en pacientes resecables. |
|
| E.2.2 | Secondary objectives of the trial |
? To estimate the effect of CT alone on pCR in marginally resectable patients.
? To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival.
? To assess tolerance |
? Estimar el efecto de la QT sola en la RCp en pacientes marginalmente resecables.
? Evaluar la tasa de RO clínica de la cirugía completa (tasa R0), supervivencia libre de eventos y supervivencia global.
? Evaluar la tolerabilidad |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
? Patients aged between 18 and 75 years
? Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC)
? Untreated locally advanced inoperable stage IIIA (only pN2 confirmed by mediastinoscopy)
? Patients with a Karnofsky Performance Status ? 80%
? Adequate pulmonary function
? Life expectancy > 12 weeks
? Patients without weight loss > 10% within the previous 3 months
? Adequate bone marrow, hepatic and renal functions:
-Neutrophils > 2.0 x 109/lL
-Platelets > 100 x 109/lL
-Haemoglobin > 12 g/dldL
-Total Bilirubin bilirubin < 1.5 x ULN
-Transaminases < 2.5 x ULN
-Alkaline phosphatase < 5 x ULN
-Glomerular Filtration Rate < 65 mlmL/min per 1.73 m2
? Presence of at least one measurable lesion (RECIST)
? Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol
? Absence of current or recent (within 2 weeks before registration) severe infection
? Absence of renal or hearing impairment
? Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
? Fertile men must be using an effective method of birth control if their partners are women of childbearing potential.
? Patients who give written (personally signed and dated) inform consent before completing any study-related procedure. |
? Pacientes de edad entre 18 y 75 años
? Con cáncer de pulmón no microcítico (CPNM) demostrado histológica o citológicamente (punción aspiración con aguja fina).
? Estadio IIIA irresecable localmente avanzado inoperable (sólo pN2 confirmado por mediastinoscopia)
? Pacientes con un Estado Funcional de Karnofsky ? 80%
? Función pulmonar adecuada
? Esperanza de vida > 12 semanas
? Pacientes sin pérdida de peso > 10% dentro de los 3 meses anteriores
? Funciones de médula ósea, hepática y renal adecuadas:
-Neutrófilos > 2.0 x 109/L
-Plaquetas >100 x 109/L
-Hemoglobina >12 g/dL
-Bilirrubina total < 1.5 x LSN
-Transaminasas < 2.5 x LSN
-Fosfatasa alcalina < 5 x LSN
-Tasa de filtrado glomerular < 65 mlmL/min por 1.73 m2
? Presencia de al menos una lesión medible (RECIST)
? Ausencia de cualquier condición psicológica, familiar, sociológica o geográfica que potencialmente obstaculice el cumplimiento del protocolo del estudio.
? Ausencia de infección grave actual o reciente (dentro de las 2 semanas anteriores al registro)
? Ausencia de afectación renal o auditiva
? Las mujeres en edad fértil deberán usar un método anticonceptivo médicamente aceptado (por ejemplo, anticonceptivos orales, dispositivos intrauterinos) para evitar un embarazo durante los 2 meses anteriores al comienzo del tratamiento del estudio, a lo largo del periodo del estudio y durante 3 meses después de la última dosis del tratamiento del estudio, de tal modo que se minimice el riesgo de embarazo. Las mujeres en edad fértil deberán tener una prueba de embarazo negativa en suero u orina en el plazo de 72 previas al comienzo del tratamiento del estudio.
? Los hombres fértiles deberán usar un método de control de natalidad eficaz si sus parejas están en edad fértil.
? Pacientes que den consentimiento informado por escrito (personalmente firmado y fechado) antes de completar cualquier procedimiento relacionado con el estudio |
|
| E.4 | Principal exclusion criteria |
? Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV.
? With tumour extent or location precluding radical radiotherapy as specified in the protocol.
? Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria
? Hearing impairment ? Grade 2
?Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment)
? Weight loss > 10% within the previous 3 months.
? Pre-existing malignant pleural effusion.
? Ascites or pericardial effusion.
? Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
? Previous or concomitant treatment with other anticancer drugs during the last 5 years.
? Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
? Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (? 20 mg/day of methyl prednisolone or equivalent).
? Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs.
? Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion.
? Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment.
? Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration. |
? Pacientes con CPNM en estadios I, II, IIIA bulky (excepto pN2 probado citologica e histologicamente), IIIB y IV.
? Con una extensión o localización del tumor que impidan radioterapia radical, como se especifica en el protocolo.
?Neuropatía sintomática (sensorial) > grado 1 según los Criterios de Toxicidad Comunes del NCI.
? Afectación auditiva ? grado 2.
? Trastorno médico concomitante/descontrolado (fallo cardiaco o infarto de miocardio dentro de los 3 meses previos; hipertensión no controlada o arritmia; hipercalcemia no controlada; infección activa que requiera antibióticos I.V. dentro de las 2 semanas anteriores al comienzo del tratamiento).
? Pérdida de peso> 10% dentro de los 3 meses anteriores.
? Derrame pleural maligno preexistente.
?Ascitis o derrame pericárdico.
? Tumoración maligna secundaria activa, excepto carcinoma in situ del cérvix tratado adecuadamente o carcinoma basocelular de la piel. Los pacientes con historia de cáncer y con al menos cinco años de seguimiento sin incidentes y sin signos de recurrencia pueden ser elegibles.
? Tratamiento previo o concomitante con otros fármacos anticancerígenos durante los últimos 5 años.
? Hipersensibilidad conocida a los fármacos del estudio, o a fármacos con similares estructuras químicas.
?Tratamiento concomitante con corticosteroides sintéticos, excepto tratamiento crónico que dure más de un mes a dosis bajas (? 20 mg/día de metil prednisolona o equivalente).
? Síndrome de malabsorción significativo o enfermedad que afecte a la función del tracto gastrointestinal y a la absorción de fármacos orales.
? Mujeres embarazadas o lactantes, o con prueba de embarazo positiva en el momento de la inclusión.
? Hombres o mujeres en edad fértil que no desean o no pueden usar un método anticonceptivo, médicamente aceptado, para evitar el embarazo durante los 2 meses anteriores al comienzo del tratamiento del estudio, a lo largo del periodo del estudio y al menos 3 meses después de la última dosis del tratamiento del estudio.
? Participación en otro ensayo clínico con cualquier estudio de fármaco en investigación (independientemente de su uso, con intención curativa, profiláctica o de diagnóstico) en el plazo de los 30 días anteriores al registro |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Pathologic complete response rate (pCR) |
| La tasa de respuesta completa patológica (RCp) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Surgery will be performed between 3 and 6 weeks after the end of either CT-RT or CT alone. In these patients, pathological examination will be performed in order to establish the pCR rate. |
|
| E.5.2 | Secondary end point(s) |
To estimate the effect of CT alone on pCR in marginally resectable patients.
To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival.
To assess tolerance |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Follow-up will continue until death. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| 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 | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| 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
|
| La fecha final de estudio será la fecha de progresión o de la recaída del último paciente evaluable, teniendo en cuenta a todos los pacientes incluidos. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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