Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.
This will be a single-cohort Phase II single center, prospective trial. Patients with stage IV NSCLC are eligible. Patients may receive standard of care systemic therapy (chemotherapy and/or immunotherapy). Radiotherapy will be directed at high-risk disease (primary cancer, nodal metastases, and metastases) in the thorax. Treatment of other sites of extrathoracic metastases would be allowed as per standard of care. Standard chest radiation dosing and normal tissue exposures (based on published or ongoing studies) will be applied. There is no plan to escalate the chest radiation dose (i.e., no Phase I component) as palliative regimens for NSCLC have been routinely used for many decades.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Prophylactic Palliative Radiotherapy
University of Rochester
Rochester, New York, United States
RECRUITINGFreedom from symptomatic progression of irradiated thoracic target(s)
Kaplan-Meier freedom from symptomatic progression of irradiated thoracic target(s) at 6 months, 1 year, and 2 years.
Time frame: 6 month, 1 year, and 2 years
OS (Kaplan-Meier) (Kaplan-Meier)
Kaplan Meier Overall Survival
Time frame: 6 month, 1 year, and 2 years
Freedom from local recurrence of irradiated thoracic target lesion(s)
Freedom from local recurrence of irradiated thoracic target lesion(s)
Time frame: 6 month, 1 year, and 2 years
PFS (freedom from local and distant progression; Kaplan-Meier)
Progression (local or distant) free survival Outcome
Time frame: 6 month, 1 year, and 2 years
Duration of time that patient is maintenance
Duration of time that patient remains on maintenance systemic therapy
Time frame: 6 month, 1 year, and 2 years
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