Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002550
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for Stage IIIA N2 Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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 Combining radiation therapy with chemotherapy may kill more tumor cells It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combining cisplatin etoposide and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combining cisplatin etoposide and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival median 2-year survival and long-term 5-year survival in patients with newly diagnosed stage IIIA N2 non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection
Secondary
Compare the patterns of local and distant failure in patients treated with these regimens
Determine the relationship of tobacco use alcohol use and diet with toxicity of these regimens and outcome in both men and women
OUTLINE This is a randomized multicenter study Patients are stratified by contralateral mediastinal sampling or biopsy yes vs no tumor stage T1 vs T2 vs T3 and performance status 70-80 vs 90-100 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5 Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Beginning within 24 hours of the first dose of chemotherapy patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2 All visible accessible bronchopulmonary hilar and mediastinal lymph nodes are excised The choice of surgical procedure thoracotomy lobectomy or pneumonectomy with en bloc resection of tumor extending into the parietal pleura chest wall pericardium or diaphragm is at the discretion of the surgeon Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2
Arm II Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2 Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days
Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 510 patients will be accrued for this study within 49 years
Primary
Compare the progression-free survival median 2-year survival and long-term 5-year survival in patients with newly diagnosed stage IIIA N2 non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection
Secondary
Compare the patterns of local and distant failure in patients treated with these regimens
Determine the relationship of tobacco use alcohol use and diet with toxicity of these regimens and outcome in both men and women
OUTLINE This is a randomized multicenter study Patients are stratified by contralateral mediastinal sampling or biopsy yes vs no tumor stage T1 vs T2 vs T3 and performance status 70-80 vs 90-100 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5 Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Beginning within 24 hours of the first dose of chemotherapy patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2 All visible accessible bronchopulmonary hilar and mediastinal lymph nodes are excised The choice of surgical procedure thoracotomy lobectomy or pneumonectomy with en bloc resection of tumor extending into the parietal pleura chest wall pericardium or diaphragm is at the discretion of the surgeon Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2
Arm II Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2 Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days
Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 510 patients will be accrued for this study within 49 years
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 |
|---|---|---|---|
| INT-0139 | None | None | None |
| CDR0000063333 | None | None | None |
| CAN-NCIC-BR13 | None | None | None |
| CLB-9592 | None | None | None |
| E-R9309 | None | None | None |
| NCCTG-R9309 | None | None | None |
| NCI-94-C-0043 | None | None | None |
| SWOG-9336 | None | None | None |