Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014196
Status:
TERMINATED
Last Update Posted:
2013-02-15
First Post:
2001-04-10
Brief Title:
S0022Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Concurrent CisplatinDocetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was closed early due to poor accrual
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 Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel cisplatin and radiotherapy followed by consolidation docetaxel
Determine the response rate in these patients when treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1 8 15 22 29 and 36 and cisplatin IV over 60 minutes on days 1 8 29 and 36 Patients also undergo concurrent radiotherapy daily 5 days per week for 65 weeks
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 30 months
Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel cisplatin and radiotherapy followed by consolidation docetaxel
Determine the response rate in these patients when treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1 8 15 22 29 and 36 and cisplatin IV over 60 minutes on days 1 8 29 and 36 Patients also undergo concurrent radiotherapy daily 5 days per week for 65 weeks
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 30 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0022 | OTHER | None | None |