INTEGRATED PROTOCOL OF CHEMO-RADIOTHERAPY IN THE TREATMENT OF THE OLD PATIENTS WITH NSCLC STAGE III. PHASE II TRIAL - ND

AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO0 个研究点开始时间: 2007年7月20日最近更新: 2012年3月19日

试验速览

暂无简介。

•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 <= 1,5 mg/dl) and hepatic (total bilirubin <= 2,0 mg/dl and levels of AST/ALT within five times the normal value);
•Absence of significative hepatic, cardiac pathology and of comorbidity that may be interfere with the therapy, the controls and the follow up;
•Informed Consent written
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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

发起方

AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO