Stage IB-II Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 8.0 Level: PT Classification code 10029518
Conditions
Interventions
Product Name: Alimta
Product Code: LY231514
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: permetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514
Other descript
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability (in terms of drug delivery and toxicity) of Cisplatin / Pemetrexed as either induction or adjuvant chemotherapy in operable patients with stage IB-II NSCLC;Secondary Objective: ;Primary end point(s): "Success of treatment delivery" and "toxicity" | — |
Countries
Belgium, United Kingdom
Outcome results
None listed