Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003364
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
Sponsor:
London Lung Cancer Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer Study 8
Status:
COMPLETED
Status Verified Date:
2007-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug with radiation therapy may kill more tumor cells The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine whether long term survival is affected by the timing of thoracic radiotherapy in patients with limited stage small cell lung cancer who are receiving combination chemotherapy II Determine whether the development of local recurrence and distant metastases are affected by the timing of thoracic radiotherapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center All patients receive cyclophosphamide doxorubicin and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes This treatment alternates every 3 weeks for six courses Patients are randomized to have thoracic radiotherapy either with course 2 arm I or with course 6 arm II of chemotherapy Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy If there is no disease progression after chemotherapy and locoregional irradiation and a repeat brain scan is negative patients receive prophylactic brain irradiation Patients are followed monthly for the first year and then every 2 months thereafter
PROJECTED ACCRUAL This study will accrue 398 patients
OUTLINE This is a randomized multicenter study Patients are stratified by center All patients receive cyclophosphamide doxorubicin and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes This treatment alternates every 3 weeks for six courses Patients are randomized to have thoracic radiotherapy either with course 2 arm I or with course 6 arm II of chemotherapy Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy If there is no disease progression after chemotherapy and locoregional irradiation and a repeat brain scan is negative patients receive prophylactic brain irradiation Patients are followed monthly for the first year and then every 2 months thereafter
PROJECTED ACCRUAL This study will accrue 398 patients
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 |
|---|---|---|---|
| EU-98011 | None | None | None |
| LLCG-TR8SCLC | None | None | None |