Randomized phase II study of adjuvant chemotherapy with cisplatin + vinorelbine vs gemcitabine + vinorelbine in stage IB-IIIA radically resected non-small cell lung cancer (NSCLC) patients - MADS
- Conditions
- non-small cell lung cancer (NSCLC)MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer
- Registration Number
- EUCTR2008-000570-21-IT
- Lead Sponsor
- IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Written informed consent
2.Age > 18 years.
3.ECOG Performance status < 1
4.No evidence of important comorbidity
5.Radical resection (R0)
6.Pathological stage IB-IIA, IIIA (T3N1 only)
7.Histological diagnosis of non-small cell lung cancer (NSCLC)
8.No prior chemotherapy for NSCLC
9.Geographic proximity for an adequate follow-up
10.Baseline hematological examination assessed within 15 days prior to the enrollement, with the following values:
Hemoglobin > 10 gr/dl
ANC > 1.500/mm3
Platelets> 100.000/mm3
Bilirubin ≤ 2 x ULN
AST, ALT, alkaline phosphatase ≤ 3.0 x ULN
Creatinine < 1.5 x ULN
Creatinine clearance ≥ 60 ml/min
11.Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment.
12.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 three years.
13.No congestive heart failure or angina pectoris except if it is medically controlled. No previous history of myocardial infarction within 6 months prior to study entry, nor uncontrolled hypertension or arrhythmia.
14.No active (uncontrolled) infection requiring antibiotics.
15.No pre-existing motor or sensory neurotoxicity ≥ grade 2 (Common Terminology Criteria for Adverse Events, Version 3.0)
16.Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment
17.Before patient randomization, written informed consent will be obtained and documented according to ICH/GCP, and italian 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
patient refusal
treatment not in the best interest of the patient, according to the responsible physician
excessive toxicity precluding further therapy, according to the responsible physician
treatment delay of more than 2 weeks
tumor progression
prior chemotherapy
pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the tolerability (in terms of drug delivery and toxicity) of cisplatin+vinorelbine and gemcitabine+vinorelbine regimens;Secondary Objective: 1.Time to progression disease<br>2.Overall survival<br>3.To achieve a biological markers- based predictive model leading to select patients that could take advantage from this treatment.<br>4.Tumor biological characterization <br>5.Integrated evaluation of cardiovascular, respiratory and of quality of life outcome;Primary end point(s): This study is designed, in each arm, according to a Bryant and Day design with the following primary endpoints<br>1. Success of treatment delivery : to be considered as a ?success? a patient should<br>a. have received 4 cycles of chemotherapy<br>b. with a relative dose intensity over the four cycles of 80% or more for each drug<br>c. have been treated according to the treatment arm allocated at randomization<br>2. Toxicity: absence of any grade 4 toxicity during chemotherapy
- Secondary Outcome Measures
Name Time Method