Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer
- There are three phases of treatment 1)chemoradiation, 2) consolidation and
- 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
To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
Aaron Allen, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|