Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002642
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
1999-11-01
Brief Title:
SWOG-9416 Chemotherapy Radiation Therapy and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Induction Chemoradiotherapy Followed by Surgical Resection for Non-small Cell Lung Cancer Involving the Superior Sulcus Pancoast Tumors A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-10
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 kill tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide radiation therapy and surgery with adjuvant therapy using cisplatin and etoposide in treating patients who have stage III non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide radiation therapy and surgery with adjuvant therapy using cisplatin and etoposide in treating patients who have stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the feasibility and toxic effects of 2 courses of cisplatinetoposide given concurrently with continuous fractionated chest irradiation followed by surgical resection and boost chemotherapy in patients with Pancoast tumors without mediastinal or supraclavicular nodal involvement II Assess the objective response rate resectability rate and proportion of patients free of microscopic residual disease after such treatment
OUTLINE All patients receive Induction on Regimen A and in the absence of progression proceed to Regimen B then C Patients who refuse or are medically unfit for surgery following Regimen A proceed directly to Regimen C Regimen A 2-Drug Combination Chemotherapy plus Radiotherapy Cisplatin CDDP NSC-119875 Etoposide VP-16 NSC-141540 plus irradiation of the tumor and ipsilateral supraclavicular region using megavoltage equipment photons with peak energies of 4-15 MV Regimen B Surgery Tumor resection Regimen C 2-Drug Combination Chemotherapy CDDP VP-16
PROJECTED ACCRUAL 99 patients will be accrued over 2-4 years
OUTLINE All patients receive Induction on Regimen A and in the absence of progression proceed to Regimen B then C Patients who refuse or are medically unfit for surgery following Regimen A proceed directly to Regimen C Regimen A 2-Drug Combination Chemotherapy plus Radiotherapy Cisplatin CDDP NSC-119875 Etoposide VP-16 NSC-141540 plus irradiation of the tumor and ipsilateral supraclavicular region using megavoltage equipment photons with peak energies of 4-15 MV Regimen B Surgery Tumor resection Regimen C 2-Drug Combination Chemotherapy CDDP VP-16
PROJECTED ACCRUAL 99 patients will be accrued over 2-4 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 |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9416 | OTHER | None | None |
| CAN-NCIC-BR11 | OTHER | None | None |
| CLB-9495 | OTHER | None | None |
| E-S9416 | OTHER | None | None |
| NCCTG-9416 | OTHER | None | None |
| INT-0160 | OTHER | None | None |