Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002623
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III 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:
RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY
Status:
COMPLETED
Status Verified Date:
2012-06
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 Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known whether chemotherapy followed by surgery with or without radiation therapy is more effective than chemotherapy followed by radiation therapy alone in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with stage IIIA non-small cell lung cancer treated with surgery with or without radiotherapy versus radiotherapy alone after achieving a response to a neoadjuvant chemotherapy regimen containing cisplatin or carboplatin
Compare the progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center response to induction chemotherapy complete vs partial vs minor and histological subtype squamous vs nonsquamous
All patients receive 3 courses of induction combination chemotherapy comprising cisplatin or carboplatin in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or minor response if disease has become resectable are randomized to 1 of 2 treatment arms
Arm I Within 6 weeks of randomization patients undergo radical lobectomy or pneumonectomy plus dissection of the hilar and mediastinal lymph nodes
Patients with positive resection margins of at least 1 cm andor positive mediastinal nodes undergo radiotherapy 5 days a week for 55 weeks
Patients with postresection subclinicalmicroscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-45 weeks
Arm II Within 6 weeks of randomization patients undergo primary radiotherapy Patients with subclinicalmicroscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-45 weeks
Patients with gross tumor volume and tumor margins at least 1 cm undergo radiotherapy 5 days a week for 6 weeks
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 640 patients will be accrued for this study within 8 years
Compare the overall survival of patients with stage IIIA non-small cell lung cancer treated with surgery with or without radiotherapy versus radiotherapy alone after achieving a response to a neoadjuvant chemotherapy regimen containing cisplatin or carboplatin
Compare the progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center response to induction chemotherapy complete vs partial vs minor and histological subtype squamous vs nonsquamous
All patients receive 3 courses of induction combination chemotherapy comprising cisplatin or carboplatin in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or minor response if disease has become resectable are randomized to 1 of 2 treatment arms
Arm I Within 6 weeks of randomization patients undergo radical lobectomy or pneumonectomy plus dissection of the hilar and mediastinal lymph nodes
Patients with positive resection margins of at least 1 cm andor positive mediastinal nodes undergo radiotherapy 5 days a week for 55 weeks
Patients with postresection subclinicalmicroscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-45 weeks
Arm II Within 6 weeks of randomization patients undergo primary radiotherapy Patients with subclinicalmicroscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-45 weeks
Patients with gross tumor volume and tumor margins at least 1 cm undergo radiotherapy 5 days a week for 6 weeks
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 640 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| EORTC-08941 | None | None | None |