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

Active, not recruiting

• Conditions: Enrolment of old patient with age over 70, with Non Small Cell Lung Cancer, not operable stage IIIA and IIIB; MedDRA version: 9.1Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage III

• Registration Number: EUCTR2007-003098-21-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <= 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified