Unresectable locally advanced non-small cell lung cancer. MedDRA version: 18.1 Level: LLT Classification code 10025053 Term: Lung cancer non-small cell stage IIIA System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Navelbine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE
CAS Number: 71486-22-1
Current Sponsor code: N
Sponsors
Grupo Español de Cáncer de Pulmón
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with confirmed histologic diagnosis of NSCLC?s in stage IIIA and IIIB unresectables. -Realization of a basal PET-CT that dismisses the presence of distant disease and confirm that it is a NSCLC not candidate to radical surgery treatment. The positive mediastinal lymph nodes for PET-CT have to be confirmed histologically. It could be considered affected mediastinic lymph nodes without necessity of verify histologically, when there is a mass at the lymph nodes area without distinguished edges. -Disease measurable by CT, as minimum one lesion. -Performance status ECOG 0-1. -Life expectation > 12 weeks. -Age ?18 years and ? 75 years. -Satisfactory renal function: creatinine ? 1.5 mg/dl or creatinine clearance > 60 ml/min. -Correct hematological function: Hemoglobin > 10 g/dl, neutrophils ? 1500, platelets ? 100000. -Correct liver function: bilirubin ? 1.5 times the maximum limit of the normality, transaminases ? 2.5 over the upper limit of the normality. -Correct lung function: defined by forced expired volume in 1 second (FEV1) >50% of normal volume, and lung diffusing capacity for carbon monoxide (DLCO) > 40% of normal value. -Lung normal proportion exposed to >20 Gy of RT (V20) have to be ? 35%. -Informed consent signature Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: -Decrease in weight > 5% in the last 3 months previous to the study entry. -Intestinal problems that do not ensure a correct absorption of oral vinorelbine. -Pregnant and lactating women. Women in childbearing age should have a negative pregnancy test, men and women under this condition should use contraceptive measures during all the clinical trial. -Symptomatic sensory neuropathy > grade 1 according with the toxicity criteria of CTCAE v4. -Non-controlled comorbidities. -Superior vena cava syndrome. -Pleural or pericardial effusion: both will be considered as metastatic disease indicators unless will be demonstrated the opposite. These that have a negative cytological for malignancy, being exudate, will be excluded too. These patients with non-visible pleural effusion in thoracic radiology or so small for realize a safe diagnostic puncture can be included. -Known hypersensitivity to drugs with similar structure of the study drugs. -Previous treatment with antineoplastic drugs or previous thoracic radiotherapy for the lung cancer or for other reason. Previous surgery for the lung cancer. -Personal background of other neoplasia, except cervical or breast carcinoma in situ and the skin basal cell carcinoma, treated in the correct way in a period of less than 5 years. -Concomitant treatment with any other antineoplastic medicine or in investigation study. - Patients in any psychological situation, familiar, sociological or geographical that can complicate the correct accomplishment of the study protocol and the following-up program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Progression free survival (PFS);Main Objective: ? To evaluate the efficacy in terms of progression-free survival (PFS) of oral metronomic vinorelbine and cisplatin as an induction treatment and posteriorly with concomitant radiotherapy. The PFS is defined as the time since the randomization until the progression documentation or exitus for any reason ( any death with or without evidence of progression, will be considered events on the exitus date and these that will not progress in the moment of the analysis will be censored with the date of the last control).; Secondary Objective: ?To describe the objective response rate of the treatment, by the target lesion assessment according with the RECIST criteria (version 1.1). ?To describe the treatment overall survival (OS). Calculated from the randomization until the death of the patient. In case that the follow-up of the patient will be lost, it will be considered the last date that it was known that the patient was alive for last time as a date for determine the survival. ?To describe the response duration time, determined since the date that it is objectified the tumor response until the progression is documented. ?To describe the safety of the treatment. ;Timepoint(s) of evaluation of this end point: Tiempo desde el momento de la aleatorización hasta el momento de la progresión o éxitus por cualquier causa sin haberse producido la progresión de la enfermedad estudiada. Es decir, los pacientes que fallezcan sin evidencia de progresión, serán considerados eventos en la fecha de éxitus y aquellos que tampoco hayan progresado en el momento del análisis, serán censurados con fecha de último control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Describir la tasa de respuesta objetiva mediante la valoración de las lesiones diana según los criterios RECIST (versión 1.1). Describir la SLP en los pacientes incluidos. Describir la supervivencia global en los pacientes incluidos calculada desde la aleatorización y hasta la muerte del paciente. En caso que el seguimiento del paciente se haya perdido se considerará la última fecha en la que se conoce que el paciente sigue vivo por última vez como fecha para la determinación de supervivencia.;Timepoint(s) of evaluation of this end point: La evaluación del tumor se realizará según las pautas RECIST (versión 1.1). La evaluación de una lesión medible se realizará en el momento basal y a las 4 semanas de la finalización del tratamiento. Los pacientes que suspendan el tratamiento del protocolo por otro motivo distinto de progresión de la enfermedad se someterán a valoraciones tumorales cada 6 semanas a partir del momento de la aleatorización hasta que se cumplan los criterios RECIST revisados (versión 1.1) sobre progresión de la enfermedad. | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
Grupo Español de Cáncer de Pulmón
Outcome results
None listed