P2.06-045 Initiative for Early Lung Cancer Research on Treatment (IELCART): Topic: LAB, Other

Abstract

Randomized controlled trial evidence to guide treatment of early stage lung cancer has been challenging for a variety of reasons. There is now increasing recognition of the power of large databases collected in the context of clinical care to provide important information and there are new statistical techniques for analysis to address unrecognized confounders. We have initiated a new multicenter, international collaborative network for this purpose. Based on an extensive literature review, scientific articles, and a series of focus sessions with a panel of expert surgeons, as well a panel of former patients, a series of critical questions regarding treatment of early lung cancer has been developed. Data forms of relevant data from both physicians and patients pre- and post-surgery to account for potential confounders have been developed, tested, and are being entered into a web-based data collection system that also includes relevant imaging data. Sites are being registered into this new network The four primary questions we found needing additional evidence that would be of most concern in regard to treatment of early lung cancer were the following•Under what circumstances should limited resection be performed?•How large should resection margins be when performing limited resection?•When should a watchful waiting approach be considered?•When should radiotherapy be considered an option for primary treatment The entire Mount Sinai Health System network which includes 5 hospitals has started enrollment. Treatment is according to usual care but documented in the IELCART registry. Four additional health systems are in the process of joining which requires completing the enrollment application and obtaining IRB approval to submit data to the IELCART registry. Since starting in March 2015, we have enrolled over 30 participants. Actual time required by the surgeon to complete the surgical data prior to surgery is a few minutes. Time to the patient and coordinator to complete the data forms prior to surgery requires between 30 and 60 minutes. We anticipate that approximately 10 health care systems will ultimately enroll in the IELCART. Within 2 years, we anticipate starting to have statistically meaningful results in answering the relevant questions. Beyond these, the IELCART registry by continuing to collect data as part of routine clinical practice will provide an important resource to answer future questions in a timely manner as they arise, including performing studies in the neo-adjuvant setting and companion diagnostics.