Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006469
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Phase II Trial of Concurrent Paclitaxel Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA N2 Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-08
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 Combining these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the response rate duration of response and survival in patients with bulky stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy followed by surgical resection
Assess the toxicity of this regimen in this patient population
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity At approximately 4 weeks after completion of chemoradiotherapy patients with stable or regressive disease undergo surgical resection If disease is unresectable patients receive an additional 2 weeks of radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-30 patients will be accrued for this study
Determine the response rate duration of response and survival in patients with bulky stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy followed by surgical resection
Assess the toxicity of this regimen in this patient population
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity At approximately 4 weeks after completion of chemoradiotherapy patients with stable or regressive disease undergo surgical resection If disease is unresectable patients receive an additional 2 weeks of radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-30 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 |
|---|---|---|---|
| NCI-V00-1632 | None | None | None |
| WHC-99444 | None | None | None |