NCT02498860

Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary endpoint : 2 year disease free survival Secondary endpoints: Overall survival, Frequency and severity of adverse events

Conditions

• Adenocarcinoma
• Lung Neoplasm

Interventions

Type	Name	Description
DRUG	Pemebit	500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
DRUG	Cisplatin	75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-02-06
• Completion: 2021-07-31
• First posted: 2015-07-15
• Last updated: 2021-08-06

Locations

7 sites across 1 country: South Korea