|- candidate number||2966|
|- NTR Number||NTR1217|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2008|
|- Secondary IDs||NVALT 8A |
|- Public Title||A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence|
|- Scientific Title||A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence|
|- ACRONYM||NVALT 8A|
|- hypothesis||The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC)|
|- Inclusion criteria||1. Age >= 18 years |
2. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
3. SUVmax < 10
4. Patients with NSCLC who had a surgical R0 resection
5. Performance score <= 2 before CT
6. Adequate organ function before administration of chemotherapy, including:
- Adequate bone marrow reserve: ANC > 1.5 x 109/L, Platelets > 100 x 109/L.
- Hepatic: bilirubin < 1.5 x ULN, AP, ALT, AST < 3.0 x ULN.
- Renal: calculated creatinine clearance > 60 ml/min based on the Cockroft and Gault formula.
7. Patients must sign and date an approved Informed Consent form.
|- Exclusion criteria||1. Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection. |
2. Prior chemotherapy or radical radiotherapy.
3. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
4. Concomitant treatment with any other experimental drug under investigation.
5. History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non-melanoma skin cancer or in situ cervical cancer.
7. Women of child-bearing potential not using effective means of contraception
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-jan-2007|
|- planned closingdate||6-jan-2011|
|- Target number of participants||864|
|- Interventions||Patients will be randomised to observational or will be treated with 4 cycles of one of the four cisplatin-based chemotherapy regimens: |
--Docetaxel (75 mg/m2 day 1) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Gemcitabine (1250 mg/m2 day 1 and 8) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Pemetrexed (500 mg/m2 day 1) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Vinorelbine (25 mg/m2 day 1 and day 8) and cisplatin (75 mg/m2) day 1 Q 3 weeks
|- Primary outcome||The main endpoint is recurrence-free survival. |
|- Secondary outcome||Secundary end-points are overall survival, dose intensity of subsequent cycles, quality of life, toxicity, health economics. Exploratory endpoints are analysis of blood and tumor samples for prognostic markers, genomics/proteomics.|
|- Timepoints||4 years follow-up|
|- Trial web site||NVALT website|
|- CONTACT FOR PUBLIC QUERIES|| D. Storm|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.J.M. Groen|
|- Sponsor/Initiator ||NVALT Oncology|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is a randomized multicenter phase III study. Patient with a low SUV of the primary tumor prior to surgery will be randomised to four cycles of cisplatin-based chemotherapy or observation in a non-inferiority design. A total of 864 patients will be entered in the study (432 patients in each arm) in 4 years. The follow up will continue for 5 years further, at the end of which a total of 150 events would be observed allowing the comparison (alpha=0.05 one-sided log-rank test.) of the curves by treatment arm with 80% power to test the non-inferiority of no chemotherapy to adjuvant chemotherapy. |
|- Main changes (audit trail)|
|- RECORD||24-dec-2007 - 25-aug-2013|