Non-Small Cell Lung Cancer Clinical Trial
Official title:
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer
This study is being done to learn what effects (good and bad) bevacizumab in conjunction with carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer (NSCLC).
- There are three phases of treatment 1)chemoradiation, 2) consolidation and
3)maintenance therapy.
- The chemoradiation phase is from week 1 to week 7. The following will occur during this
phase: Daily chest radiation starting on day 1; pre-medication for paclitaxel; weekly
intravenous administration of paclitaxel and carboplatin; intravenous administration of
bevacizumab once weekly every three weeks starting on day 1.
- During weeks 8-9, patients will undergo a PET/CT scan for restaging.
- The consolidation phase is from week 10 to week 16. The following will occur during
this phase: Pre-medication for paclitaxel; intravenous administration of paclitaxel and
carboplatin twice weekly every 3 weeks; intravenous administration of bevacizumab once
weekly every 3 weeks.
- The maintenance phase is from week 17 to week 52. The following will occur during this
phase; intravenous administration of bevacizumab once a week every three weeks for 1
year; PET/CT scan every three months.
- The following evaluations will occur during treatment: 1)Patients will be evaluated
weekly by the study doctor, 2) Weight, difficulty or discomfort in swallowing,
shortness of breath and over well-being will be recorded, 3) Weekly lab test will
include CBC, chemistries, and liver function tests. 4) Followed through each cycle of
chemotherapy and every 6-8 weeks for the duration of the study.
- The following evaluations will occur after treatment: 1)Every 6-8 weeks assessed for
response with a CT or PET/CT scan for one year, 2) Toxicity will also be assessed at
each follow-up interval.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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