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Maintenance Chemotherapy versus Consolidative Stereotactic Body Radiation Therapy (SBRT) plus Maintenance Chemotherapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03137771
Protocol IDs
NRG-LU002 (primary)
NRG-LU002
NCI-2016-00849
Study Sponsor
NRG Oncology

Summary

This randomized phase II 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, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor 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 tumor 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.

Objectives

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

SECONDARY OBJECTIVES:
I. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival.
II. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on in-field local failure.
III. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on primary failure.
IV. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on out-of-field disease progression.
V. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on toxicity.
VI. To evaluate the impact of adding SBRT to maintenance chemotherapy versus maintenance chemotherapy alone on duration of maintenance chemotherapy usage.

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, erlotinib hydrochloride orally (PO) once daily (QD), 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 over 2-4 weeks. If SBRT cannot be used to treat primary disease sites, patients also undergo intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3DCRT) over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive 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.

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