Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003812
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
TopotecanPaclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer A 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 Combining more than one drug and giving them before and with radiation therapy may be an effective treatment for limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the complete response rate to 2 courses of paclitaxel and topotecan followed by consolidation chemoradiotherapy in patients with limited stage small cell lung cancer II Determine the toxic effects of this regimen in this patient population III Describe the pattern of relapse documenting carefully the location of relapse with respect to the original disease volume and the radiation treatment field in these patients IV Determine the overall and failure free survival of these patients
OUTLINE Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1 Filgrastim G-CSF is administered subcutaneously every day starting on day 6 until blood counts recover The course is repeated once beginning on day 22 After restaging patients begin thoracic radiotherapy daily five days per week for 6-7 weeks On the same day that radiotherapy begins patients receive carboplatin IV over 1 hour day 43 and etoposide IV over 1 hour daily for 3 days days 43-45 The consolidation chemotherapy is repeated every 21 days for a total of 3 courses Patients with stable or responding disease undergo prophylactic cranial irradiation Patients are followed at least every 3 months for 2 years every 6 months for 3 years and then at least every year
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 15-18 months
OUTLINE Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1 Filgrastim G-CSF is administered subcutaneously every day starting on day 6 until blood counts recover The course is repeated once beginning on day 22 After restaging patients begin thoracic radiotherapy daily five days per week for 6-7 weeks On the same day that radiotherapy begins patients receive carboplatin IV over 1 hour day 43 and etoposide IV over 1 hour daily for 3 days days 43-45 The consolidation chemotherapy is repeated every 21 days for a total of 3 courses Patients with stable or responding disease undergo prophylactic cranial irradiation Patients are followed at least every 3 months for 2 years every 6 months for 3 years and then at least every year
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 15-18 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-39808 | None | None | None |
| CDR0000066958 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |