| - candidate number | 2504 |
| - NTR Number | NTR924 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 5-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small lung cancer (NSCLC) of any stage. |
| - Scientific Title | Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small lung cancer (NSCLC) of any stage. |
| - ACRONYM | Pre-operative chemotherapy. |
| - hypothesis | The hypothesis is that the 3-year survival will increase from 40 to 55% in the preoperative chemotherapy arm. |
| - Healt Condition(s) or Problem(s) studied | Non small cell lung cancer (NSCLC) |
| - Inclusion criteria | 1. Previously untreated, microscopically proven NSCLC diagnosed at the local centre from biopsy or cytology; 2. Tumour considered resectable by the surgeon; 3. Either sex, any age; 4. No evidence of distant metastases; 5. Considered fit for chemotherapy and proposed surgical resection; 6. WHO performance status 0, 1 or 2, namely: ambulatory and capable of all self-care and up and about more than 50% of waking hours, whether or not able to work (WHO, 1979); 7. No contraindication to chemotherapy or surgery; 8. No other disease or previous malignancy likely to interfere with the protocol treatments or comparisons; 9. Patient willing and able to complete SF-36 QL questionnaires; 10. Informed consent obtained; 11. First SF-36 questionnaire completed. |
| - Exclusion criteria | See inclusion criteria. |
| - 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 | 17-jul-2001 |
| - planned closingdate | 29-jun-2005 |
| - Target number of participants | 519 |
| - Interventions | Chemotherapy for EORTC and NVALT participants: each center should choose only one schedule: 1. Three cycles of chemotherapy with gemcitabine 1250 mg/m² on days 1 and 8 and cisplatin 80 mg/m² on day 1 will be administered before surgery. Cycles are repeated every 3 weeks. Cisplatin is administered after gemcitabine on day 1; 2. Three cycles of chemotherapy with docetaxel 75 mg/m² and carboplatin AUC= 6 will be used on day 1 every 3 weeks before surgery starts. |
| - Primary outcome | The primary aim is the 3-year survival rate after surgical resection with or without pre-operative chemotherapy. |
| - Secondary outcome | 1. Quality of life throughout the survival period; all items on the SF-36 questionnaire will be used to assess physical, emotional and functional health status, with particular emphasis on items that reflect the impact of symptoms on activities; 2. Pre-randomisation clinical and post-surgery pathological staging; 3. Resectability rates; 4. Extent of surgery; 5. Time to and site of relapse. And in the chemotherapy group, to document: a. response according to recist (1999) criteria, and; b. clinician’s assessment of the adverse effects of chemotherapy. |
| - Timepoints | N/A |
| - Trial web site | http://www.nvalt-oncology.nl |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Prof. Dr. MD. PhD. E.F. Smit |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. H.J.M. Groen |
| - Sponsor/Initiator | NVALT, MRC Trial Organisation |
| - Funding (Source(s) of Monetary or Material Support) | Eli Lilly Nederland B.V., Asta Medica, The Netherlands, Aventis Pharma, The Netherlands |
| - Publications | Lancet. 2007 Jun 9;369(9577):1929-37. |
| - Brief summary | Chemotherapy in non-resectable non-small lung cancer could reduce the local tumor. At the same time occult metastases may reduce with systemic chemotherapy. The prognosis of these patients with resectable tumor may improve after chemotherapy. The study group are patients with a resectable NSCLC and by randomisation patients will be divided into those with or those without preoperative chemotherapy. There was no "gold standard" chemotherapy schedule for NSCLC, although five cispatinum containing regimens, are being widely used. For this study different chemotherapy schedules will be used. For NVALT two schedules were choosen. 1. Three cycles of chemotherapy with gemcitabine 1250 mg/m² on days 1 and 8 and cisplatin 80 mg/m² on day 1 will be administered before surgery. Cycles are repeated every 3 weeks. Cisplatin is administered after gemcitabine on day 1; 2. Three cycles of chemotherapy with docetaxel 75 mg/m² and carboplatin AUC= 6 will be used on day 1 every 3 weeks before surgery starts. The primary aim is to compare 3-year survival following surgical resection with or without pre-operative chemotherapy. Secondary aims are to compare: 1. QL throughout the survival period; all items on the SF-36 questionnaire will be used to assess physical, emotional and functional health status, with particular emphasis on items that reflect the impact of symptoms on activities; 2. pre-randomisation clinical and post-surgery pathological staging; 3. resectability rates; 4. extent of surgery; 5. time to and site of relapse and in the chemotherapy group, to document; 6. response according to recist (1999) criteria; 7. clinician’s assessment of the adverse effects of chemotherapy. |
| - Main changes (audit trail) | |
| - RECORD | 5-mrt-2007 - 9-jul-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl