Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005022
Status:
COMPLETED
Last Update Posted:
2013-11-03
First Post:
2000-04-06
Brief Title:
Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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 chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy in patients with small cell lung cancer II Evaluate the response rate and overall survival in these patients III Reduce the toxic effects of treatment to esophagus and lungs
OUTLINE This is a radiation dose escalation study Patients are sequentially accrued to one of four radiation dose levels Dose level 1 Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days then twice daily for 3 days during week 5 Closed to accrual 698 Dose level 2 Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5 Closed to accrual 92499 Dose level 3 Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20 then twice daily for 5 days during week 5 Closed to accrual 5500 Dose level 4 Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20 then twice daily for 5 days during week 5 The fifth dose level is the same as the first dose level Closed to accrual 31999 Cohorts of 5 patients are entered at each radiation dose level If one patient experiences nonhematologic dose limiting toxicity DLT 5 additional patients are treated at that level If no further DLT occurs escalation to the next arm proceeds Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-10 months
OUTLINE This is a radiation dose escalation study Patients are sequentially accrued to one of four radiation dose levels Dose level 1 Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days then twice daily for 3 days during week 5 Closed to accrual 698 Dose level 2 Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5 Closed to accrual 92499 Dose level 3 Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20 then twice daily for 5 days during week 5 Closed to accrual 5500 Dose level 4 Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20 then twice daily for 5 days during week 5 The fifth dose level is the same as the first dose level Closed to accrual 31999 Cohorts of 5 patients are entered at each radiation dose level If one patient experiences nonhematologic dose limiting toxicity DLT 5 additional patients are treated at that level If no further DLT occurs escalation to the next arm proceeds Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-10 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 |
|---|---|---|---|
| CDR0000065797 | None | None | None |