Clinical Trials

Title   NRG LU002
Principal Investigator/ Physician   Weisi Yan, MD
Protocol┬áNo.   LU002
Open Date   05/24/2017
Gender   Both
Cancer Site   Lung
Status   Closed
Sponsor   NRG
Contact Email   MCI Clinical Trials

Protocol: 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 

Inclusion Criteia: Zubrod performance status 0, 1, or 2 within 30 days prior to registration; must have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response; Prior systemic chemotherapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC; Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable;must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT.

Exclusion Criteria: Clinical or radiologic evidence of untreated and/or progressive brain metastases; Cutaneous metastasis of NSCLC; Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes; Prior invasive malignancy unless disease free for a minimum of one year;  receiving targeted therapy; progressed in previous areas of primary disease that received definitive doses of radiation; more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct metastatic disease entities; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.


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