non small cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10062042 Term: Lung neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CARBOPLATINO
Product Name: CARBOPLATINO
Product Code: [CARBOPLATINO]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CARBOPLATINO
Current Sponsor code: carboplatino
Concen
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between the ages of 18 and 75. Patients with NSCLC with a stologically proven diagnosis. Clinically non-metastatic patients at a distance (CT or MRI negative for metastases cerebral, chest CT complete abdomen or PET-CT with 18 fluorine-desoxy-glucose negative for distant metastasis) before enrollment Patients undergoing lobectomy or sublobar resection and ilo-medistinic lymphadenectomy. Patients treated surgically with macroscopically radical resection (R0-R1) with mediastinal lymph node involvement (pN2), any stage of T. ECOG Performance Status 0-1 No other surgical, chemotherapy or radiotherapy treatments for neoplasia, except of non-melanoma tumors of the skin or in situ tumor of the cervix and other solid tumors which radical treatment was completed at least three years before it was entered into study and for which the patient has remained continuously free of disease. Signature of informed consent. Possibility of access to follow-up. Preoperative systemic staging with chest CT, full abdomen CT, brain CT with contrast medium or alternatively brain NMR without and with contrast medium or PET 18FDG and TC brain with contrast medium or MRI (performed within 90 days prior to randomization). Interval between surgery and start of treatment not exceeding 60 days 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Metastatic disease for pre-operative investigations. cN3 finding at pre-surgery staging exams. Patients undergoing neoadjuvant chemotherapy (pre-surgery). Respiratory function tests (PFR) with FEV1 <1.5 liters or DLCO <50% predicted. Chronic hepatic failure in stage B and C according to Child-Pugh classification. Grade IV kidney failure (creatinine clearance <30 ml / min). Pregnancy or breastfeeding. allergy to the study drugs or to the excipients used in them formulation One of the following conditions: - Myocardial infarction in the 12 months prior to randomization - Severe congestive heart failure (NYHA class III-IV) - Unstable angina - Cardiomyopathy in progress - Ventricular arrhythmia - Uncontrolled arterial hypertension - Uncontrolled diabetes - Serious psychotic disorders in progress - Severe infection in progress - Any other serious illness that could interfere with the administration of the therapy foreseen by the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: investigate which is the best combination temporal treatment of chemotherapy and radiotherapy in patients undergoing resection Surgery for NSCLC pN2. compare directly postoperative radiotherapy and sequential or concomitant chemotherapy in patients with NSCLC pN2, - Evaluation of the incidence and degree of acute oesophageal toxicity according to the CTCAE criteria version 4.0 - Evaluation of survival free from locoregional relapse;Secondary Objective: Evaluation of overall survival (Overall survival, OS), survival cause specific (disease specific survival, DSS) progression-free survival (progression free survival, PFS), survival free from distant metastases (freedom from distant metasis, FFDM). Evaluation a of acute pulmonary and cardiac toxicity (within 30 days from term of treatment defined according to the CTCAE criteria) Evaluation of defined late pulmonary, cardiac and esophageal toxicity according to the CTCAE criteria version 4.0;Primary end point(s): Efficacy endpoint: Evaluation and comparison of locoregional relapse-free survival Toxicity endpoint: evaluation and comparison of the incidence and degree of acute esophageal toxicity (within the first 4 months from the end of the treatment) according to the CTCAE version 4.0 criteria;Timepoint(s) of evaluation of this end point: Efficacy point: at each check Toxicity endpoint: 4th month and at each check | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Overall survival, OS, sdisease specific survival, DSSprogression free survival, PFS,freedom from distant metasis, FFDM;Timepoint(s) of evaluation of this end point: at each check | — |
Countries
Italy
Contacts
Public ContactProgettazione Ricerca Clinica e Stu
ASST degli Spedali Civili di BRescia
Outcome results
None listed