Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Official Title

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Summary:

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumour cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumour using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Trial Description

Primary Outcome:

• Phase II - Progression-Free Survival (PFS)
• Phase III - Overall Survival (OS)

Secondary Outcome:

• Time to In-Field Failure
• Time to Out-of-Field Failure
• Incidence of adverse events graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4
• Duration of Maintenance Chemotherapy Usage

PRIMARY OBJECTIVES:
Phase II

• To evaluate the impact of adding stereotactic body radiation therapy (SBRT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy.

Phase III

• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy.

SECONDARY OBJECTIVES:

• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure.
• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on primary failure.
• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on out-of-field disease progression.
• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity.
• To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic chemotherapy usage.
• To evaluate the effect of adding SBRT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL)

OUTLINE:
Patients are randomized into 1 of 2 arms.

ARM 1 (CHEMOTHERAPY ALONE): Patients may receive docetaxel intravenously (IV) over 60 minutes on Day 1, or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM 2 (SBRT AND CHEMOTHERAPY): Patients undergo SBRT to all sites of metastases (≤3 discrete sites) plus irradiation of the primary site (SBRT or hypofractionated RT) followed by chemotherapy as in Arm 1.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

View this trial on ClinicalTrials.gov