Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma|
- Resectability rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of participants with perioperative complications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, cisplatin and bevacizumab.
Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab followed by surgical resection
This trial investigates the role of neoadjuvant pemetrexed, cisplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588704
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Si-Yu Wang, Doctor||Sun Yat-sen University|