Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033553
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2002-04-09
Brief Title:
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
InductionConcurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer A Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy It is not yet known which chemotherapy andor radiation therapy regimen is more effective in treating non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall response rate failure-free survival and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy 3-D XRT vs gemcitabine and carboplatin with concurrent 3-D XRT
Compare the toxicity of these regimens in these patients
Compare the pattern of failure locoregional vs distant failure in patients treated with these regimens
Determine the feasibility of delivering 3-D XRT to patients in this multicenter study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy 3-D XRT once daily 5 days a week Treatment repeats weekly for 7 courses
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I Treatment repeats weekly for 7 courses
In both arms treatment continues in the absence of disease progression
Patients are followed every 2 months for 2 years every 4 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 82 patients 41 per treatment arm will be accrued for this study within 9 months
Compare the overall response rate failure-free survival and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy 3-D XRT vs gemcitabine and carboplatin with concurrent 3-D XRT
Compare the toxicity of these regimens in these patients
Compare the pattern of failure locoregional vs distant failure in patients treated with these regimens
Determine the feasibility of delivering 3-D XRT to patients in this multicenter study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy 3-D XRT once daily 5 days a week Treatment repeats weekly for 7 courses
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I Treatment repeats weekly for 7 courses
In both arms treatment continues in the absence of disease progression
Patients are followed every 2 months for 2 years every 4 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 82 patients 41 per treatment arm will be accrued for this study within 9 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069300 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-30105 | None | None | None |