Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021112
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin etoposide and radiotherapy followed by surgical resection
Determine the toxicity morbidity and mortality of this regimen in these patients
Determine the clinical response rate and pathological response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3 Chemotherapy repeats every 3 weeks for 3 courses Beginning on day 2 of the second course of chemotherapy patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity
At 3-6 weeks after completion of the last dose of induction radiotherapy patients undergo lobectomy or pneumonectomy
Patients are followed at 30 days and 4 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 27-62 patients will be accrued for this study
Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin etoposide and radiotherapy followed by surgical resection
Determine the toxicity morbidity and mortality of this regimen in these patients
Determine the clinical response rate and pathological response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3 Chemotherapy repeats every 3 weeks for 3 courses Beginning on day 2 of the second course of chemotherapy patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity
At 3-6 weeks after completion of the last dose of induction radiotherapy patients undergo lobectomy or pneumonectomy
Patients are followed at 30 days and 4 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 27-62 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 |
|---|---|---|---|
| EORTC-08981 | None | None | None |