Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
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| First Received Date ICMJE | April 25, 2012 | ||||
| Last Updated Date | April 30, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Resectability rate [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01588704 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Perioperative complications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] Perioperative complications, such as major hemoptysis, wound healing complications, and infection. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma | ||||
| Official Title ICMJE | A Phase II Study of Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma | ||||
| Brief Summary | 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. |
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| Detailed Description | This trial investigates the role of neoadjuvant pemetrexed, cisplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab followed by surgical resection
Other Names:
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| Study Arm (s) | Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, cisplatin and bevacizumab.
Intervention: Drug: Neoadjuvant Bevacizumab |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 36 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01588704 | ||||
| Other Study ID Numbers ICMJE | wsy002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Siyu Wang, Sun Yat-sen University | ||||
| Study Sponsor ICMJE | Siyu Wang | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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