Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004011
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
S9900 Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative PaclitaxelCarboplatin in Clinical Stage IB T2N0 II T1-2N1 T3N0 and Selected IIIA T3N1 Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2013-01
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 more than one drug may kill more tumor cells It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare survival of patients with previously untreated stage IB II or selected IIIA non-small cell lung cancer after preoperative chemotherapy comprising paclitaxel and carboplatin plus surgery vs surgery alone
Compare these regimens in terms of operative mortality and other toxic effects in these patients
Evaluate the response rates confirmed and unconfirmed and toxic effects associated with combined paclitaxel and carboplatin in these patients
Obtain samples for correlation of radiologic pathologic molecular and biologic factors with the outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical stage IB or IIA vs IIB or IIIA
Patients are randomized to one of two treatment arms
Arm I Patients undergo thoracotomy All accessible hilar level 10 lymph nodes are dissected and complete mediastinal lymph node sampling is performed
Arm II Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Within 2-6 weeks of course 3 patients undergo thoracotomy and lymph node dissection as in arm I
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually until year 10
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 4 years
Compare survival of patients with previously untreated stage IB II or selected IIIA non-small cell lung cancer after preoperative chemotherapy comprising paclitaxel and carboplatin plus surgery vs surgery alone
Compare these regimens in terms of operative mortality and other toxic effects in these patients
Evaluate the response rates confirmed and unconfirmed and toxic effects associated with combined paclitaxel and carboplatin in these patients
Obtain samples for correlation of radiologic pathologic molecular and biologic factors with the outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical stage IB or IIA vs IIB or IIIA
Patients are randomized to one of two treatment arms
Arm I Patients undergo thoracotomy All accessible hilar level 10 lymph nodes are dissected and complete mediastinal lymph node sampling is performed
Arm II Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Within 2-6 weeks of course 3 patients undergo thoracotomy and lymph node dissection as in arm I
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually until year 10
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 4 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 |
|---|---|---|---|
| S9900 | OTHER | None | None |
| S9900 | OTHER | None | None |
| S9900 | OTHER | None | None |
| RTOG-L0015 | OTHER | None | None |
| U10CA032102 | NIH | RTOG | httpsreporternihgovquickSearchU10CA032102 |