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October 2005

Prospective Phase- Preventing Low Birth Weight Babies: The Role of Primary Prevention

Principal Investigator: Stephen D. Ratcliffe, MD

Collaborators: Andrew S. Coco, MD; Michael A. Horst, PhD

Sponsor: Family Medicine Education Consortium

Objective: This project will prepare family medicine faculty and residents to use what is known about primary prevention to decrease the rates of prematurity and low weight babies. Thirteen family medicine residency programs will implement an improved curriculum and process of care that will improve how patients are cared for in their respective office practices. This application is for the prospective CQI implementation of the project. A previous application has been approved (03/15/05) for the retrospective phase of the project to collect baseline data.


Neuroform Microdelivery System

Principal Investigator: Oleg E. Bronov, MD

Collaborators: John Briguglio, MD; Edgar C. Fearnow, III, MD; Robert E. Gress, MD; Robert F. Latshaw, MD; Paul A. Leslie, MD; Leigh S. Shuman, MD

Sponsor: None

Objective: To use the Neuroform Microdelivery Stent system as a Humanitarian Use Device (HUD) as outlined in the Humanitarian Device Exemption (HDE) guidelines for the treatment of patients with wide neck intracranial aneurysms.


E1304: Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (VELCADEÔ) in Combination with Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients with Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Principal Investigator: Thomas O’Conor, MD

Collaborators: Robert J. Gottlieb, MD; Ashok Beedassy, MD; Shyam Balepur, MD; Elizabeth Horenkamp, MD; Samuel J. Kerr, MD

Sponsor: ECOG

Objective: The primary objective is to evaluate the activity of PS-341 and Irinotecan in patients with locally advanced, recurrent or metastatic SCCHN and the response rate of single agent PS-341 (followed by Irinotecan at time of progression).


RTOG 0412/SWOG 0332: Phase III Randomized Trial of Preoperative Chemotherapy versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with Stage IIIa (N2) Non-Small Cell Lung Cancer

Principal Investigator: Thomas O’Conor, MD

Collaborators: Robert J. Gottlieb, MD; Ashok Beedassy, MD; Shyam Balepur, MD; Elizabeth Horenkamp, MD; Samuel J. Kerr, MD

Sponsor: RTOG/SWOG

Objective: The primary objective of this analysis is to prove that the preoperative regimen, consisting of thoracic radiation therapy given concurrently with chemotherapy followed by surgical resection, results in a significant improvement in overall survival compared to preoperative chemotherapy alone followed by surgical resection, with both arms receiving postoperative consolidation therapy.