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NCT00002583
Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
Phase 3 trial testing cisplatin in Lung Cancer in 482 participants. Completed in 21 December 2009.
25 April 2004
Quick facts
| Lead sponsor | NCIC Clinical Trials Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 482 |
| Start date | 7 July 1994 |
| Primary completion | 25 April 2004 |
| Estimated completion | 21 December 2009 |
| Sites | 155 locations across Canada, United States |
Drugs / interventions tested
- cisplatin (cisplatin) — full drug profile →
- vinorelbine ditartrate — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
NCIC Clinical Trials Group
Who can join
Adults 18 to 120, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is more effective than no further treatment for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
SMARCA4/BRG1 Is a Novel Prognostic Biomarker Predictive of Cisplatin-Based Chemotherapy Outcomes in Resected Non-Small Cell Lung Cancer.
Bell EH, Chakraborty AR, Mo X, Liu Z, et al · · 2016 · cited 129× · PMID 26671993 · DOI 10.1158/1078-0432.ccr-15-1468 -
Pooled Analysis of the Prognostic and Predictive Effects of TP53 Comutation Status Combined With KRAS or EGFR Mutation in Early-Stage Resected Non-Small-Cell Lung Cancer in Four Trials of Adjuvant Chemotherapy.
Shepherd FA, Lacas B, Le Teuff G, Hainaut P, et al · · 2017 · cited 90× · PMID 28453411 · DOI 10.1200/jco.2016.71.2893 -
Quality-of-life outcomes for adjuvant chemotherapy in early-stage non-small-cell lung cancer: results from a randomized trial, JBR.10.
Bezjak A, Lee CW, Ding K, Brundage M, et al · · 2008 · cited 59× · PMID 18809617 · DOI 10.1200/jco.2007.12.6094
Verify or expand the search:
- PubMed search for NCT00002583
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other NCIC Clinical Trials Group trials
Trials by the same sponsor.
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- NCT01830621 — BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma · Phase 3 · completed
- NCT01652144 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00002583 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NCIC Clinical Trials Group
- Last refreshed: 3 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002583.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing