Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043108
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2002-08-05
Brief Title:
Combination Chemotherapy Surgery and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Trimodality Protocol for the Treatment of Locally Advanced Potentially Resectable Non-Small Cell Lung Cancer Targeting
Status:
COMPLETED
Status Verified Date:
2022-01
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 Radiation therapy uses high-energy x-rays to damage tumor cells Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin
Determine the survival event-free survival and incidence of pathologic complete remission of patients treated with this regimen
Determine the protocol completion rate CR of patients treated with this regimen
Determine the feasibility and toxicity of this regimen in these patients
Determine the pathologic response ratedownstaging pathologic near CR rate freedom from distant metastasis rate and freedom from local regional failure rate of patients treated with this regimen
OUTLINE Patients receive induction therapy comprising radiotherapy 5 days a week for 55-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36
Within 1-3 weeks after completion of induction therapy patients undergo restaging Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1 8 and 15
Within 4-12 weeks after surgery or additional chemoradiotherapy patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1 Adjuvant treatment repeats every 4 weeks for 3 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 57 patients will be accrued for this study within 4 years
Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin
Determine the survival event-free survival and incidence of pathologic complete remission of patients treated with this regimen
Determine the protocol completion rate CR of patients treated with this regimen
Determine the feasibility and toxicity of this regimen in these patients
Determine the pathologic response ratedownstaging pathologic near CR rate freedom from distant metastasis rate and freedom from local regional failure rate of patients treated with this regimen
OUTLINE Patients receive induction therapy comprising radiotherapy 5 days a week for 55-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36
Within 1-3 weeks after completion of induction therapy patients undergo restaging Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1 8 and 15
Within 4-12 weeks after surgery or additional chemoradiotherapy patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1 Adjuvant treatment repeats every 4 weeks for 3 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 57 patients 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?:
False
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 |
|---|---|---|---|
| 02-014 | OTHER | FCCC IRB | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| NCI-G02-2097 | OTHER | None | None |