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A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence


- candidate number2966
- NTR NumberNTR1217
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2008
- Secondary IDsNVALT 8A  
- Public TitleA randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence
- Scientific TitleA randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence
- ACRONYMNVALT 8A
- hypothesisThe 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) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. 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 criteria1. 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.
6. Pregnancy
7. Women of child-bearing potential not using effective means of contraception
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jan-2007
- planned closingdate6-jan-2011
- Target number of participants864
- InterventionsPatients 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 outcomeThe main endpoint is recurrence-free survival.
- Secondary outcomeSecundary 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.
- Timepoints4 years follow-up
- Trial web siteNVALT website
- statusstopped
- CONTACT FOR PUBLIC QUERIES D. Storm
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J.M. Groen
- Sponsor/Initiator NVALT Oncology
- Funding
(Source(s) of Monetary or Material Support)
NVALT Oncology
- PublicationsN/A
- Brief summaryThis 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)
- RECORD24-dec-2007 - 25-aug-2013


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