Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256789
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2005-11-18
Brief Title:
Once Weekly Radiation for Lung Cancer With Chemotherapy
Sponsor:
Clinical Oncology Research Associates
Organization:
Clinical Oncology Research Associates
Study Overview
Official Title:
Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This program is designed for the treatment of patients with advanced non-small cell lung cancer The study is designed for patients whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer Patients at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession Recently the administration of both methods of treatment has been employed and preliminary studies indicate somewhat better results Specifically a new class of chemotherapy agents called taxanes used in combination with radiation therapy appear promising as determined in small studies However the best treatment for this type of cancer has not been established yet One goal of this study is to investigate if the combination of the new drug Taxotere a drug belonging to the taxane class given on the day of the radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to traditional radiation therapy In this study the radiation will be given on one day rather than divided over five days per week Monday through Friday as in previous studies Previous research has shown that both equal in how effective they are in treating lung cancer The study will use the drug Taxotere in conjunction with radiation therapy Taxotere is an approved medicine by the United States Food and Drug Administration for the treatment of lung cancer
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once weekly together with concurrent radiation on the same day is effective in shrinking non-small cell lung cancer This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once weekly together with concurrent radiation on the same day is effective in shrinking non-small cell lung cancer This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants
Detailed Description:
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 20mgm2 In our unpublished phase I clinical trial we found 35 mgm2 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
Chemotherapy The suggested phase II dose for weekly Taxotere with concomitant standard chest radiotherapy was determined to be 20mgm2 In our unpublished phase I clinical trial we found 35 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None