Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003231
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Preoperative Chemotherapy in Non-Small Cell Lung Cancer NSCLC Patients With Mediastinal Lymph Node Metastases Stage IIIA N2
Status:
COMPLETED
Status Verified Date:
2019-05
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 Combining more than one drug with surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients with stage IIIA non-small cell lung cancer II Assess the clinical and pathological response rate to this therapy in this patient population III Compare the benefit of surgery in terms of overall survival of responding and nonresponding patients
OUTLINE Patients receive infusions of docetaxel over 1 hour on day 1 followed by infusions of cisplatin over 1 hour on days 1-2 Treatment is repeated for three 21 day courses Patients undergo tumor resection and mediastinal lymph node dissection Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins andor the first mediastinal lymph node levels are involved Patients will be followed until death
PROJECTED ACCRUAL Approximately 5-40 patients will be accrued within 3 years
OUTLINE Patients receive infusions of docetaxel over 1 hour on day 1 followed by infusions of cisplatin over 1 hour on days 1-2 Treatment is repeated for three 21 day courses Patients undergo tumor resection and mediastinal lymph node dissection Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins andor the first mediastinal lymph node levels are involved Patients will be followed until death
PROJECTED ACCRUAL Approximately 5-40 patients will be accrued within 3 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 |
|---|---|---|---|
| EU-97034 | None | None | None |
| SWS-SAKK-1696 | None | None | None |