Non Small Lungcancer (NSCLC) (NLD: Niet Kleincellig Longcarcinoom).
Conditions
Interventions
Arm 1: Carboplatin AUC 5 mg/ml/min on day 1 - gemcitabine 1250 mg/m2 on days 1 and 8 of a three week cycle, for a maximum of 4 cycles.
Arm 2: Carboplatin AUC 5 mg/ml/min on day 1 - paclitaxel 175 m
Sponsors
NVALT
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed inoperable (stage III) or disseminated (stage IV) non small cell lung cancer; 2. No previous chemo- and or radiotherapy; 3. Age =/> 70 years; 4. WHO performance status =/ 3.0 x 109/L, neutrophils =/> 1.5 x 109/L, platelets =/> 100 x 109/L; 8. Adequate renal function: creatinine clearance =/> 50 mL/min (Cockcroft formula); 9. Adequate liver function: serum aspartate aminotransferase (ASAT/SGOT) and serum alanine aminotransferase (ALAT/SGPT) less than 1.5 times the upper normal limit for the institution, total serum bilirubin within the normal limits for the institution, alkaline phosphatase less than 5 times the upper normal limit for the institution (unless bone metastases are present in the absence of any liver disease); 10. Patients must understand the study, be willing to comply with the scheduled visits and give written informed consent before starting the study.
Exclusion criteria
Exclusion criteria: 1. Patients with a mixed form of NSCLC and SCLC; 2. Active uncontrolled infection; 3. Presence of CNS metastases; 4. Symptomatic sensory peripheral neuropathy =/> grade 1 according to NCIC Common Toxicity Criteria; 5. Patients with uncorrected hypercalcemia; 6. Unstable peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids; 7. Unstable cardiac conditions; 8. Concomitant administration to any other experimental drugs under investigation. However, patients should continue on their usual medications.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity of both treatment arms; 2. Response rate in each treatment arm; 3. Survival of both treatment arms (overall survival, median survival, 1 year survival as well as progression free survival); 4. Geriatric assessments and serial assessments of quality of life and looking at: a. Are there determinants in the CGA that could be used as a tool to predict which patients benefit from chemotherapy in terms of improvement in quality of life and experienced toxicity; b. Is there a correlation between the GFI and the Karnofsky score and/or performance score according to WHO?; c. Is there a correlation between GFI and toxicity of therapy?; d. Is there a correlation between GFI and response to therapy?; e. Is there a difference in baseline scores in CGA/GFI in patients accepting chemotherapy between an university hospital or general hospital? (indication for referral filter); f. Does tumor response correlate with (changes in) global quality of life?; 5. The utilization of health care resources will be prospectively studied by counting the number of hospital days. | — |
Primary
| Measure | Time frame |
|---|---|
| To compare changes in quality of life between the two treatment groups from baseline as compared with quality of life at 18 weeks after start treatment. | — |
Contacts
Public ContactA.N.M. Wymenga
Medisch Spectrum Twente Department of Pulmonary Diseases
Outcome results
None listed