drugset / Trial / NCT02498860
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
Phase 2
Completed
106 enrolled
Chonnam National University Hospital
Chungnam National University Hospital · collabKorea University Guro Hospital · collabKosin University Gospel Hospital · collabKyungpook National University Hospital · collabPusan National University Hospital · collabSeverance Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Two-Year Disease Free Survival Rate of Stage IB\~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.
Timeline
- Start
- 2015-09-01
- Primary completion
- 2018-02-06
- Completion
- 2021-07-31
Outcome
Met primary endpoint
paper Adjuvant Pem-Cis is superior to historical control without adjuvant treatment in terms of 2-year DFSR; PMID 36090637 ↗
Publications
- Results Kreuter M, Vansteenkiste J, Fischer JR, Eberhardt W, Zabeck H, Kollmeier J, Serke M, Frickhofen N, Reck M, Engel-Riedel W, Neumann S, Thomeer M, Schumann C, De Leyn P, Graeter T, Stamatis G, Zuna I, Griesinger F, Thomas M; TREAT investigators. Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. Ann Oncol. 2013 Apr;24(4):986-92. doi: 10.1093/annonc/mds578. Epub 2012 Nov 15.
- Results Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.
- Results Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91. doi: 10.1056/NEJMoa060570.
- Park CK, Oh HJ, Yoo SS, Lee SY, Lee SH, Kim EY, Lee SY, Choi J, Lee MK, Kim MH, Jang TW, Chung C, Oh IJ, Kim YC. Open-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial. Transl Lung Cancer Res. 2022 Aug;11(8):1606-1618. doi: 10.21037/tlcr-22-183.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Pemebit | Unknown | 500 mg/m2 | — |