Randomized Phase II Study Of Pemetrexed And Cisplatin As Either Induction or Adjuvant Chemotherapy In Stage IB-II Non-Small Cell Lung Cancer (NSCLC)

• Conditions: Stage IB-II Non-Small Cell Lung Cancer (NSCLC); MedDRA version: 8.0Level: PTClassification code 10029518

• Registration Number: EUCTR2005-003822-25-BE
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

? Pathological proven NSCLC.
? Performance status: WHO = 2.
? Age > 18 years.
? Clinical stage IB-II NSCLC: cT2N0M0, cT1N1M0, cT2N1M0 or cT3N0M0.
? No evidence of mediastinal involvement as assessed by either mediastinoscopy and/or FDGPET scan.
? No evidence of metastatic disease as assessed by routine dissemination analysis according to institutional practice.
? Tumor considered resectable by multidisciplinary team.
? Presence of at least one measurable lesion (using RECIST criteria)
? No prior therapy for NSCLC (chemotherapy, radiotherapy or surgery).
? Adequate hematological function:
? ANC > 1.5 x 109/L
? Platelets> 100 x 109/L
? Hemoglobin > 10 g/dl (6,2 mmol/l)
? Adequate renal function:
? calculated creatinine clearance = 60 ml/min (see appendix C for calculating the
creatinine clearance according to the Cockroft-Gault formula)
? Adequate hepatic function:
? bilirubin = 1.5 x ULN
? alkaline phosphatase = 3.0 x ULN
? AST/ALT = 3.0 x ULN
? The patient should be physically and mentally fit enough to receive chemotherapy in either adjuvant or neo-adjuvant setting and to undergo the proposed resection. A multidisciplinary team will confirm the required fitness.
? No other malignant disease, with the exception of basocellular carcinoma of the skin, adequately treated carcinoma in situ of the cervix, low-grade prostate cancer or other cancer from which the patient has been disease-free for at least last five years.
? No congestive heart failure or angina pectoris except if it is medically controlled. No previoushistory of myocardial infarction within 6 months prior to study entry, nor uncontrolled hypertension or arrhythmia.
? No active (uncontrolled) infection requiring antibiotics.
? No pre-existing motor or sensory neurotoxicity = grade 2 (Common Terminology Criteria forAdverse Events, Version 3.0)
? Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment
? Before patient randomization, written informed consent will be obtained and documented according to ICH/GCP, and national/local regulations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

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