Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer

NCT00913705 ↗

Phase 3 Completed 624 enrolled Spanish Lung Cancer Group

RandomizedParallel-groupOpen-labelTreatment

Summary

Open-label multicenter randomized Phase III trial.

Timeline

Start: 1999-09
Primary completion: 2007-12
Completion: 2009-06

Outcome

Missed primary endpoint

paper no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. PMID 20516435 ↗

Publications

Results Felip E, Rosell R, Maestre JA, Rodriguez-Paniagua JM, Moran T, Astudillo J, Alonso G, Borro JM, Gonzalez-Larriba JL, Torres A, Camps C, Guijarro R, Isla D, Aguilo R, Alberola V, Padilla J, Sanchez-Palencia A, Sanchez JJ, Hermosilla E, Massuti B; Spanish Lung Cancer Group. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3138-45. doi: 10.1200/JCO.2009.27.6204. Epub 2010 Jun 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	6 unknown	—
Subject	Carboplatin	Small molecule	200 mg/m2	—