The NVALT-3 study.
| - candidate number | 2505 |
| - NTR Number | NTR925 |
| - ISRCTN | incomplete |
| - 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 |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - 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. |
| - Timepoints | N/A |
| - 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 |
| - Funding (Source(s) of Monetary or Material Support) | Amgen, Eli Lilly Nederland B.V. |
| - Publications | N/A |
| - 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 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl