NCT01725165

Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer

A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Induced Oligometastatic Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well surgery and/or radiation therapy or standard therapy and/or clinical observation works in treating patients with previously treated stage IV non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells. Giving surgery and/or radiation therapy may be more effective than standard therapy and/or clinical observation in patients with previously treated non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine whether oligometastatic non-small cell lung cancer (NSCLC) patients with no disease progression after first line therapy have prolonged progression free survival (PFS) when treated with local consolidation therapy (LCT) of residual disease (radiation or surgery) followed by maintenance or surveillance as per physician choice compared with no LCT. SECONDARY OBJECTIVES: I. Determine the overall survival. II. Safety/tolerability of LCT. III. Time to progression of prior metastatic lesions. IV. Time to appearance of new metastases (central nervous system \[CNS\] vs. extra-CNS, treated lesion vs. new site). V. Quality of life (QOL). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (IMMEDIATE LCT): Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or external beam radiation therapy (EBRT). After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician. ARM II (DELAYED/NO LCT): Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to Response Evaluation Criteria in Solid Tumors (RECIST) progression or toxicity at the treating physician's discretion. After completion of study treatment, patients are followed up for 9 months.

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Clinical Observation	Undergo clinical observation
RADIATION	External Beam Radiation Therapy	Undergo EBRT
OTHER	Laboratory Biomarker Analysis	Optional correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Standard Follow-Up Care	Undergo standard maintenance therapy
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2012-11-28
• Primary completion: 2024-05-08
• Completion: 2024-05-08
• First posted: 2012-11-12
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

3 sites across 2 countries: United States, Canada