Volume 2: ISSUE 6: March 24, 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: AZ1071, A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis E1208, A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion. NCCTG/NO577, Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma RTOG 0539, Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas. RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis.
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. GOG258, 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 RTOG0627, Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme, will be opened to the JKCCN only 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. SWOG0521, A Randomized Trial of Maintenance Versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III. If your site is interested in participating in any of these studies please contact Rolma Gano at 215-955-7954 or Rolma.gano@jeffersonhospital.org.
Regulatory Update: The following studies have had recent consent form changes or updated letters posted on the repository website: RTOG 0813 ECOG 1208 CALGB90401 CALGB90601 ECOG2805 RTOG0848 RTOG0538/CALGB30610 If any of these studies pertain to your site please visit the repository at: http://www.kimmelcancercenter.org/kcc/jkccn/file-repository/. Please contact Rolma Gano with any repository or other regulatory related questions. Quality Assurance Update: Please continue to check your online calendars for forms due and outstanding queries, in order to ensure timely data submission and query resolution. Data management tools can be found via NSABP's Coordinator Online system, ECOG's Expectancy and edcf systems, RTOG's Site Tools, and the CTSU Clinical Data website feature. Please contact Kelly Shipman with any QA related issues at 215-955-2135 or Kelly.shipman@jeffersonhospital.org. CTSU Update: The following protocols are coming soon to the OPEN system: E3508 and ACOSOG-Z1071. 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 215-955-0048 or Joshua.schoppe@jeffersonhospital.org.
ECOG Update: ECOG Tissue Consent Survey: The ECOG Patient Representative Committee is asking for your help. An issue that has become very important to cancer clinical research is when, if ever, is it appropriate to mandate in our trials patient consent for immediate use or banking of pathologic specimens. To help us understand how ECOG members feel about mandating tissue consent in our trials, ECOG has developed a survey that takes only a few minutes of your time, and could provide us with very valuable insights into this complex issue. Please help ECOG by providing your input via this survey. It can be completed on the web at http://www.surveymonkey.com/s/8ld3qqp ECOG Performance Monitoring: The next Performance Monitoring data cut-off date of 3/31/2010 is approaching. Any data received on or before 3/31/2010 will be included in the upcoming Performance Monitoring. Data received after 3/31/2010 will be considered late. It is important to remember that data timeliness will be evaluated by assessing two components: The rate of CRF submitted and the rate of survival follow-up. To avoid penalties, each evaluable ECOG institution must have a score of 90% or better on each component. 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. https://www.regonline.com/ecog_spring2010
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 22-25. The registration link below is not posted on the NSABP website. http://www.meetingsinfo.com/hotelinformation/san_francisco/home.html Registration deadline has passed but it may still be possible to register. A tentative meeting schedule has been posted on the registration website. NSABP P-5, Statin Polyp Prevention Trial in Patients with Resected Colon Cancer, was activated on March 11, 2010. This is a phase III interventional trial for patients with resected stage I or II colon cancer. Stratification factors are family history of a first degree relative with colorectal cancer, intended aspirin dose (zero vs. 81mg vs. 325mg) and adjuvant therapy for colon cancer. Randomization is to placebo tablet daily x 5 years vs. rosuvastatin 10mg tablet once daily x 5 years. The primary aim is to determine if the administration of 5 years of postoperative rosuvastatin affects 5 year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma and colon cancer recurrence in patients with resected colon cancer. The accrual goal is 1,740. Major eligibility criteria include surgical resection completed within 1 year before randomization and adjuvant therapy, if given, completed before randomization. Patients with hereditary colon cancer syndromes are excluded. See the NSABP Website for the complete protocol. Please mark your calendar for the NSABP audit scheduled for June 21, 2010. 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.
If you have an NSABP related question please contact Vicki Squire at vicki.squire@kimmelcancercenter.org or at 215-503-5641. 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 http://rtog.org/meeting/main.html. Please preregister via the following link: https://registrations.acr.org/rtog/. Trial spotlight: Recently, the manuscript for RTOG 0236 was published in JAMA. This trial found that highly-focused stereotactic body radiation therapy (SBRT) can eliminate the targeted tumor while avoiding treatment-related illness and may ultimately improve survival for patients with inoperable nonsmall cell lung cancer. Stereotactic body radiation therapy (SBRT) is a noninvasive cancer treatment in which numerous small, highly focused, and accurate radiation beams are used to deliver potent doses in 1 to 5 treatments to tumor targets. Patients on this trial who received SBRT had a survival rate of 55% at 3 years, high rates of local tumor control, and moderate treatmentrelated morbidity. The complete manuscript can be found at http://jama.amaassn.org/cgi/content/short/303/11/1070?home. 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: http://www.kimmelcancercenter.org/jkccn/. 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 22-25 JOG Investigator Meeting, Philadelphia: May 10 ECOG Spring Meeting, Washington, D.C.: June 11-13 RTOG Semiannual Meeting, Philadelphia, PA: June 17-20 The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: http://www.kimmelcancercenter.org/jkccn/e-newsletters.html Please provide feedback and any suggestions to Joshua Schoppe at 215-955- 0448 or email Joshua.schoppe@jeffersonhospital.org