Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy
Status:
Withdrawn
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
Summary
The study is designed for patients with non small cell lung cancer whose cancer is too
advanced and therefore cannot be operated with the goal of completely removing the cancer. At
this stage of the disease, most patients cannot be cured from the disease, however, treatment
can help to live longer and better by keeping the cancer under control. For that purpose,
patients traditionally receive radiation therapy or chemotherapy or both treatments in
succession. Recently, the administration of both treatment methods given concurrently showed
somewhat better results when compared to successive administration. In some studies the drug
Taxotere together with radiation performed well in keeping the cancer better under control.
Combination of the drug Taxotere together with a compound called 5-FU either as continuous
infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity
substantially.
One goal of this study is to investigate how much of the combination can be given in
conjunction with chest radiation. Using X-rays, the study will also evaluate how much
shrinkage of the cancer is caused by this treatment directly at the tumor site and other
areas where the cancer may have also spread.
In this study the radiation will be given on only one day per week in two sessions, rather
than divided over five days per week (Monday through Friday) as it is more commonly used.
However, both schedules have been found to be equally effective.
The treatment program will use increasing doses of the 5-FU medication, either as infusion or
as pill to find the highest dose that is tolerated. Once the highest tolerated dose is
determined, subsequent patients who will be enrolled will continue to be treated at that dose
level. The dose of the drug Taxotere will remain the same throughout.
Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given
together with weekly chest radiation will provide a more convenient form of treatment than
the conventional approach and also be at least similar in its efficacy.