Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT00776100
Status:
TERMINATED
Last Update Posted:
2017-03-06
First Post:
2008-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated prematurely due to slow accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* To assess whether the addition of radiotherapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival of patients with oligometastatic stage IV non-small cell lung cancer.
Secondary
* To compare the progression-free survival of patients treated with radiotherapy vs observation after standard chemotherapy.
* To compare the time to disease progression and time to treatment failure in these patients.
* To compare the confirmed response rate in these patients.
* To compare the duration of response in these patients.
* To compare the adverse events in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with bevacizumab during first-line chemotherapy (yes vs no), number of standard chemotherapy courses (2-3 vs 4-6), Linear Analog Self Assessment value (≤ 7 vs \> 7), and histology (predominantly squamous cell vs not predominantly squamous cell). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo observation for 6 weeks.
* Arm II: Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
After completion of study therapy, patients are followed every 3-6 months for up to 5 years.
Primary
* To assess whether the addition of radiotherapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival of patients with oligometastatic stage IV non-small cell lung cancer.
Secondary
* To compare the progression-free survival of patients treated with radiotherapy vs observation after standard chemotherapy.
* To compare the time to disease progression and time to treatment failure in these patients.
* To compare the confirmed response rate in these patients.
* To compare the duration of response in these patients.
* To compare the adverse events in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with bevacizumab during first-line chemotherapy (yes vs no), number of standard chemotherapy courses (2-3 vs 4-6), Linear Analog Self Assessment value (≤ 7 vs \> 7), and histology (predominantly squamous cell vs not predominantly squamous cell). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo observation for 6 weeks.
* Arm II: Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
After completion of study therapy, patients are followed every 3-6 months for up to 5 years.
Study Oversight
Has Oversight DMC:
False
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?: