The Clinical Research E-News

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1 Volume 2: ISSUE 8: April 21, 2010 The Clinical Research E-News SPECIAL ALERT: The annual JOG investigator Meeting will be held at 5:30pm on May 10, 2010 at the Loews Hotel. Coming soon: NSABP FC-6, A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mfolfox7 Plus Cetuximab for Unresectable Wild-Type K-RAS Colorectal Cancer with Metastases Confined to the Liver E2508, A Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients with (Bevacizumab-eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC) E3903, Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders. RTOG0627, Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme, will be opened to the JKCCN only SWOG0521, A Randomized Trial of Maintenance Versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III. ECOG 3805,CHAARTED - Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

2 CALGB 70604, A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer RTOG 0937, Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) RTOG 0915, Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer RTOG 0618, A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer ECOG 1697, Phase III Randomized Study of Four Weeks High Dose IFN-A2B in Stage T2B NO, T3A-B NO, T4A-B NO, and T1-4, N1A, 2A, 3 (microscopic) Melanoma CALGB10403, An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL) If your site is interested in participating in any of these studies please contact Rolma Gano at or Rolma.gano@jeffersonhospital.org. Regulatory Update: The following studies have had recent consent form changes or updated letters posted on the repository website: E4A03 R0413 R0227 S0307 (closure to accrual letter)

3 E1508 VELOUR C40502 E3903 R0413 NSABP FB6 R0413 (amendment #4 letter) BETH E2905 If any of these studies pertain to your site please visit the repository at: Please contact Rolma Gano with any repository or other regulatory related questions. Quality Assurance Update: Please contact Kelly Shipman with any QA related issues at or CTSU Update: The following protocols are now available on the OPEN system: E2804, E1208 and E1A06. Please see the OPEN tab on the CTSU Members web site for more information about the protocols in OPEN. SWOG0421, Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer, will permanently close to accrual effective May 1, 2010 as it has met its accrual goal. If you have a CTSU related question please contact Joshua Schoppe at or Joshua.schoppe@jeffersonhospital.org. ECOG Update: ECOG Spring Meeting: The ECOG spring meeting will be held at the JW Marriott Hotel in Washington, D.C., June 11 th through the 13 th. Meeting registration will be done online again for this meeting. To register for the

4 Group Meeting, please use the link below. Please note that the schedule is updated on an ongoing basis. The schedule provided is for current reference only and is subject to change at any time. ECOG strongly recommends that all meeting attendees check the most current schedule online before making travel arrangements, as ECOG will not be responsible for ticket change fees due to scheduling changes. If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: NSABP audit: Please mark your calendar for the NSABP audit scheduled for June 21, The chart of any JKCCN NSABP patient accrued in the last 3 years may be selected for audit. We will be notified of the announced charts on May 24, STAR: A reanalysis of STAR data with 81 months of follow-up has been completed. STAR investigators presented this update and additional data at the 101st Annual Meeting of the American Association for Cancer Research (AACR) in Washington D.C. on Monday, April 19th. A comprehensive article reporting the trial and analysis was published in this week's NCI Cancer Bulletin. Follow up for the participants in the STAR trial is challenging, but this reanalysis demonstrates the importance of long term data. A special thank you to our hard-working STAR coordinators! The link to the NCI bulletin publication is below: If you have an NSABP related question please contact Vicki Squire at vicki.squire@jeffersonhospital.org or at

5 RTOG Update: The next RTOG Semiannual meeting will be held June 17-20, 2010, at the Loews Philadelphia Hotel in Philadelphia, PA. General information about the meeting can be found at Please preregister via the following link: Jefferson Oncology Group (JOG) Update: If your site has any JOG inquires please contact either Josh Schoppe or Vicki Squire. Jefferson Kimmel Cancer Center Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository. Upcoming Events: NSABP Group Meeting, San Francisco: April JOG Investigator Meeting, Philadelphia: May 10 ECOG Spring Meeting, Washington, D.C.: June RTOG Semiannual Meeting, Philadelphia, PA: June The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe at or