|- candidate number||2505|
|- NTR Number||NTR925|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-mrt-2007|
|- Secondary IDs||N/A |
|- Public Title||A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life: |
The NVALT-3 study.
|- Scientific Title||A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life: |
The NVALT-3 study.
|- ACRONYM||Chemotherapy in elderly patients|
|- hypothesis||Gemcitabine-carboplatin is better tolerable than paclitaxel-carboplatin in elderly patients having advanced NSCLC as assessed with quality of life questionnairs.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC)|
|- 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 =/< 2;
5. Estimated life-expectancy of concomitant diseases for at least six months;
6. Measurable disease on physical examination, chest X-ray, or CT-scan;
7. Adequate bone marrow reserve: Leukocytes =/> 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2003|
|- planned closingdate||1-aug-2006|
|- Target number of participants||182|
|- 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 mg/m2 on day 1 of a three week cycle, for a maximum of 4 cycles.
Carboplatin dose will be calculated according to the Calvert formula
Pretreatment a comprehensive geriatric assessment (CGA) will be performed by a specialized research nurse.
|- Primary outcome||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.|
|- Secondary outcome||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.
|- Trial web site||http://www.nvalt-oncology.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD A.N.M. Wymenga |
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD A.N.M. Wymenga |
|- Sponsor/Initiator ||NVALT|
(Source(s) of Monetary or Material Support)
|Amgen, Eli Lilly Nederland B.V.|
|- Brief summary||In this phase III study we want to determine which platinum-based treatment is optimal in elderly patients (=/>70 years) having advanced NSCLC. Therefore we compare carboplatin-paclitaxel with carboplatin-gemcitabine to a maximum of 4 cycles and assess both regimens in terms of quality-of-life, toxicity, response rate and especially geriatric assessments. Our hypothesis is that elderly NSCLC patients are able to tolerate polychemotherapy and show improvement after this treatment. We will perform a complete geriatric assessment to evaluate whether these tests can be used as a tool to predict which patient will benefit from chemotherapy.|
|- Main changes (audit trail)|
|- RECORD||5-mrt-2007 - 2-dec-2008|