The Clinical Research E-News

Transcription

1 Volume 2: ISSUE 7: April 7, 2010 The Clinical Research E-News SPECIAL ALERT: The annual JOG investigator Meeting will be held at 5pm on May 10, 2010 at the Loews Hotel. Now Open: RTOG0831, A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated with Radiotherapy for Prostate Cancer. GOG 258, A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma 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.

2 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 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 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:

3 JOG 49 PACCT-1 ECOG 4805 SWOG 0600 RTOG 0848 RTOG 0539 RTOG 0631 GOG258-New Activation RTOG0831- New Activation RTOG 0415 CALGB RTOG 0848 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: E1208. Please see the OPEN tab on the CTSU Members web site for more information about the protocols in OPEN. If you have a CTSU related question please contact Joshua Schoppe at or Joshua.schoppe@jeffersonhospital.org. ECOG Update: The ECOG Registration System will be unavailable on Wednesday April 7, between 4:30 PM and 5:30 PM Eastern time, so that CTSU can activate E1208 in the OPEN system. E2805: Addendum #9 will be released on April 28, This addendum contains changes to the adverse event section and risks section of the consent for both Sorafenib and Sunitinib. This addendum will be submitted to the

4 TJUH IRB and it will be at their discretion to mandate a re-consent of all patients on study. Once this addendum is approved by the TJUH IRB we will notify all sites on how to proceed for all current E2805 patients. 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 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 Group Meeting: Registration is now open for the NSABP Group Meeting in San Francisco scheduled for April The registration link below is not posted on the NSABP website. Registration deadline has passed but it may still be possible to register. A tentative meeting schedule has been posted on the registration website. 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, 2010.

5 If you have an NSABP related question please contact Vicki Squire at or at 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: The March issues of the RTOG 0436, RTOG 0539, and RTOG 0617 newsletters were just issued and can be found at the following locations: Newsletter.pdf If you have an RTOG related question please contact Kelly Shipman. 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: Oral Cancer Screening Event, TJU: April 14, 2010 NSABP Group Meeting, San Francisco: April JOG Investigator Meeting, Philadelphia: May 10 ECOG Spring Meeting, Washington, D.C.: June 11-13

6 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