Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062439
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2003-06-05
Brief Title:
S0220 Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Induction Chemoradiotherapy With CisplatinEtoposide Followed by Surgical Resection Followed by Docetaxel for Non-Small Cell Lung Cancer Involving the Superior Sulcus Pancoast Tumors
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 such as cisplatin etoposide and docetaxel 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 cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery Giving docetaxel after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors a type of non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors a type of non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus Pancoast tumors
Determine overall survival of patients treated with this regimen
Determine time to progression in patients treated with this regimen
Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE
Induction chemoradiotherapy Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1 8 29 and 36 Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks
Within 2-4 weeks after completion of induction chemoradiotherapy patients undergo disease evaluation Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete
Consolidation chemotherapy Within 3-8 weeks after thoracotomy patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4-6 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
Determine the feasibility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus Pancoast tumors
Determine overall survival of patients treated with this regimen
Determine time to progression in patients treated with this regimen
Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE
Induction chemoradiotherapy Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1 8 29 and 36 Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks
Within 2-4 weeks after completion of induction chemoradiotherapy patients undergo disease evaluation Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete
Consolidation chemotherapy Within 3-8 weeks after thoracotomy patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4-6 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
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 |
|---|---|---|---|
| S0220 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |