This phase I trial studies the side effects and best dose of cyclical hypofractionated palliative radiation therapy (Quad Shot) in relieving symptoms of patients with stage IV non-small cell lung cancer. Radiation therapy is frequently used to relieve symptoms in patients with non-small cell lung cancer that has spread to other places in the body (advanced or metastatic). The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules. The purpose of this trial is to find out whether Quad Shot radiation treatments can relieve the symptoms of non-small cell lung cancer while causing few or mild side effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04384146.
PRIMARY OBJECTIVE:
I. To assess the safety of up to 3 cycles of Quad Shot palliative radiation therapy in patients with stage IV non-small cell lung cancer (NSCLC) receiving systemic therapy.
SECONDARY OBJECTIVES:
I. To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to stage IV NSCLC patients.
II. To assess treatment toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 at baseline and at the time of each quad shot cycle as well as 3 weeks, 3 months and 6 months after treatment.
III. To estimate patient symptom relief and quality of life, including an expansion cohort, using European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 and EORTC QLQ-Core (C)30 at baseline and at the time of each quad shot cycle as well as 3 weeks, 3 months and 6 months after treatment.
IV. To assess the rate of delay or disruption of systemic therapy due to radiation toxicity.
V. To assess lesion local control at 6 months.
VI. To assess patient overall survival at 6 months.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo Quad Shot palliative radiation therapy twice daily (BID) over 2 days for 2 cycles in the absence of unacceptable toxicity, with a 21-28 day break in between cycles.
GROUP II: Patients undergo Quad Shot palliative radiation therapy BID over 2 days in the absence of unacceptable toxicity. If there are =< 1 dose-limiting toxicities in Group I, patients undergo 2 additional cycles of Quad Shot palliative radiation therapy in the absence of unacceptable toxicity, with a 21-28 day break in between cycles.
Additionally, patients undergo computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed up at 3 weeks and at 3 and 6 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJennifer Ma
