Enrolment of old patient with age over 70, with Non Small Cell Lung Cancer, not operable stage IIIA and IIIB MedDRA version: 9.1 Level: LLT Classification code 10029519 Term: Non-small cell lung cancer stage III
Conditions
Interventions
Trade Name: CISPLATINO MAYNE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Trade Na
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hystological or cytological diagnosis of NSCLC; Stage IIIA and IIIB (excluded the N3 sovraclavear and/or T4 for positive pleural cytology); ECOG Performance Status 0-1; Age >= 70 years; Not previous chemotherapy; Life expectancy of at least 12 weeks; PFR (FEV1>45%; DLCO>45% of the theoretical value) Adeguate bone marrow reserve: granulocytes >= 1500; platelets >= 100.000; hemoglobin >=10 gr/dl; ? Normal renal function (creatinin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Active or uncontrolled infections Hystory present or past of allergy Significant cardiovascular pathology Uncontrolled Diabetes Mellitus Weight dicrease >10% Second tumor within previous 5 years (except carcinoma in situ of the portio, cutaneous carcinoma, superficial carcinoma of the blister with radical treatment) Impossibility to perform a follow-up quickly if a significant toxicity is present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of the schedula proposed with induction phase and integrated chemo-radiotherapy treatment.;Secondary Objective: duration of response progression-free survival and median survival treatment toxicity quality of life and control the symptoms in the patient treated if the use of erythropoietin is able to modify positively the response to the integrated treatment of CT/RT maintaining Hb values up to 11 g/dl and therefore to increase the effect of the RT; the eventual protective role of the erythropoietin on the peripheral nervous system from the treatment with cisplatin and vinorelbine. the efficiency of the geriatric multidimensional evaluation;Primary end point(s): To evaluate the activity of the schedula proposed with induction phase and integrated chemo-radiotherapy treatment. | — |
Countries
Italy
Outcome results
None listed