NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS WITH BRAIN METASTASES MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Trade Name: MUPHORAN*IV 1F 208MG+F SOLV
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Fotemustine
CAS Number: 92118-27-9
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: 1 Histologically or cytologically confirmed diagnosis of adnaced NSCLC; 2.Brain metastases, radiologically measurable with TC or MNR, clinically asymptomatic and not amenable to definitive locoregional treatment 3 No prior chemotherapy 4 Males or females aged between 18 and 70 years; 5 ECOG Performance Status 0 or 1 6 Adequate laboratory requirements at entry - Blood cell counts: Absolute neutrophils > 2.0 . 109/L; Platelets > 100 . 109/L; Hemoglobin > 10 g/dl Renal function: Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA: 1 History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years; 2 Prior brain radiotherapy 3 Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia; 4 Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up; 5 Active infection requiring iv antibiotics; 6 Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy; 7 Current peripheral neuropathy NCI grade > 2; 8 Participation in clinical trials with other experimental agents within 30 days of study entry;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY ENDPOINT: Activity and tolerability of Cisplatin and Fotemustine combination with radiotherapy in paztients with advanced NSCLC and brain metastases not amenable to definitive locoregional treatment;Secondary Objective: SECONDARY ENDPOINT: To evaluate the toxicity of this combination and its impact in order to the QoL (Quality of Life) of this patients, survival, time to progression and duration of response;Primary end point(s): PRIMARY ENDPOINT: Activity and tolerability of Cisplatin and Fotemustine combination with radiotherapy in paztients with advanced NSCLC and brain metastases not amenable to definitive locoregional treatment | — |
Countries
Italy
Outcome results
None listed