Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study
40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV)
and treated once per week for a total of 12 cycles (12 weeks) according to the schedule
outlined below.
Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard
chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial,
we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II
study. The drug will be administered intravenously on the same day as the radiation. All
patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will
be followed and evaluated weekly by a physician.
Radiation therapy: Although radiation was delivered differently in previous Taxotere based
combined modality studies, the total radiation dose remains the same. Treatment will be
given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas
will be radiated as well. To reduce volume toxicity, the “field within a field” technique
will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12
treatments will be administered in weekly, single sessions. Total treatment will be 6000
cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility
Paul Schwarzenberger, MD
Principal Investigator
Mobile Infirmary Hospital, Mobile, AL
United States: Institutional Review Board
Hypo 1
NCT00256789
September 2002
November 2007
Name | Location |
---|---|
Cancer Center and Mobile Infirmary Hospital | Mobile, Alabama 36607 |