Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00776100|
Recruitment Status : Terminated (Study was terminated prematurely due to slow accrual.)
First Posted : October 20, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: clinical observation Radiation: radiation therapy||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Patients undergo observation for 6 weeks.
Other: clinical observation
Patients undergo observation for 6 weeks.
Experimental: Arm II
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for 6 weeks.
- Overall Survival [ Time Frame: Time from registration to death or last follow-up (up to 5 years) ]Overall survival was defined as the time from registration to the date of death or last follow-up
- Response Rate [ Time Frame: Up to 5 years ]A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.
- Progression-free Survival [ Time Frame: Time from registration to disease progression or death (up to 5 years) ]Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.
- Time to Disease Progression [ Time Frame: Time from registration to disease progression (up to 5 years) ]Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
- Time to Treatment Failure [ Time Frame: Up to 5 years ]Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.
- Duration of Response [ Time Frame: Up to 5 years ]Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776100
|Study Chair:||Steven E. Schild, MD||Mayo Clinic|