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Upstate Active Clinical Trials

Study Title:

IELCART: Initiative for Early Lung Cancer Research on Treatment

What is the purpose of the study?

The Initiative for Early Lung Cancer Research for Treatment (IELCART) has its broad research objective the advancement of knowledge about optimal for treatment of clinical Stage I lung cancer. It addresses the call by the Institute of Medicine to provide novel methods of addressing critical questions in the context of clinical medical practice (1) and also the call by the National Institute of Health to provide alternative, valid and efficient study designs (2). IELCART is a natural and critical step towards achieving that goal.

This protocol focuses on identifying optimal surgical treatment among the surgical treatment and radiotherapy treatment as well as other treatments including watchful waiting.

Key questions for surgical treatment of a first primary clinical Stage I lung cancer are:

1) What is the optimal extent of the surgical resection for curative treatment given individual characteristics of both the patient and the cancer?
2) When and to what extent should mediastinal lymph node resection be performed?
3) If sublobar resection is to be performed, what is the minimal tumor-normal tissue margin?
4) Is watchful waiting another option for certain subtypes of lung cancer?

These are four important issues for minimizing the extent of the surgical procedure (i.e., sublobar resection and no mediastinal lymph node resection) decreases the time and morbidity of the surgical procedure, preserves pulmonary function, and increases the likelihood of resection of future new occurrences of lung cancers.

The research program of IELCART is guided by a common protocol which specifies the necessary documentation according prior to treatment, during and after treatment, and long-term follow-up after diagnosis. To address the treatment questions, all patients diagnosed with clinical Stage I disease presenting at the participating institutions for any treatment will be registered in the IELCART database.
Participation in this research study is expected to last for up to 10 years after treatment with contact/follow up at least once a year.
This is an observational study. Enrollment goal is 5,000 patients in 3 years.

Upstate Institutional Review Board (IRB) Number:

1023967

Study/Protocol ID:

IELCART

Study Phase:

NA

Patient Age Group:

Adults

Principal Investigator:

Leslie J Kohman, MD, FACS

Who is eligible?

All patients with a first primary clinical Stage I (N0M0) lung cancer who will undergo surgical, radiotherapy, watchful waiting or any other treatment will be enrolled prior to treatment at each participating institution.

Who can I contact for more information?

Name: Linda J Ellinwood, RN
Phone: 315-464-1852
Email: ellinwol@upstate.edu

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