The Clinical Research E-News

Transcription

1 Volume 3: ISSUE 11: June 15, 2011 The Clinical Research E-News Reminder: CRA Quarterly Meeting, Philadelphia, PA: 10-11am on Wednesday June 22nd- Virtual Meeting: dial information attached in a separate document. Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: Now Open: SWOG 1007, A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. Coming soon: ACOSOG Z1041, A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with HER-2 Positive Operable Breast Cancer C70604, A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer E1809, Randomized Phase II Trial of Docetaxel with or without PSATRICOM Vaccine in Patients with Castrate-Resistant Metastatic Prostate Cancer

2 E2108, A Randomized Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Women with Metastatic Breast Cancer E6508, A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation E7208, A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy. RTOG 0933, A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases--RTOG CCOP Study RTOG 1008, A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors If your site is interested in participating in any of these studies please contact Rolma Gano at or Rolma.gano@jeffersonhospital.org. Regulatory Update: NSABP B-39: Amend #5 RTOG0617 RTOG0848 RTOG0413: Tissue Consent NSABP FC-6 RTOG0524: Amends #6-7 GOG262: S0777: Revision #11 S1007: New study Letter None of these changes require a re-consent. Please contact Rolma Gano with any repository or other regulatory related questions.

3 CTSU Update: N0147, A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5- Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer, has transitioned the data management from CTSU to NCCTG. As described in recent communications, the NCCTG assumed all data management responsibilities for N0147 on June 1, At this time, we request that you: 1) Send all paper forms and data directly to NCCTG. 2) Continue to fax any form that has been previously faxed to NCCTG. 3) Send all responses to any existing CTSU issues, Data Clarification Forms or requests directly to NCCTG. 4) Please use the following address for the mailing of N0147 paper documents: NCCTG Operations Office Attention: Quality Assurance Office (Study N0147) RO FF-3-24-CC/NW Clinic 200 First Street SW Rochester, MN Please contact Joshua Schoppe with any CTSU related issues at or Joshua.Schoppe@jeffersonhospital.org ECOG Update: PACCT-1, Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial, recently released a memorandum calling for all delinquent data to be resolved before a scheduled interim analysis. In order to prepare for the analysis there will be increased communication from the CTSU Data Management staff in the form of Data Clarification Forms (DCFs), s, and phone calls. Delinquent Data Reminders will be ed from the CTSU to site data administrators on the 1st and 15th of each month.

4 Upcoming Performance Monitoring: The next Performance Monitoring data cut-off date of June 30, 2011 is approaching. Any data received on or before June 30, 2011 will be included in the upcoming Performance Monitoring. Data received after June 30, 2011 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. The Spring 2011 ECOG Update Newsletter is available for access and download on the ECOG website. You can view and/or print your copy by visiting the following link: If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy, a revised worksheet for the NSABP B-43 Request for Transmittal Form for Pre-entry HER2 Testing Specimen (Form RUMC Request), dated June 13, 2011, can be downloaded from the CTSU Web site. The sole revision to the document is the addition of a "Group Credited" field. The earlier version of the form dated August 3, 2009 should no longer be used. If you have an NSABP related question please contact Vicki Squire at vicki.squire@jeffersonhospital.org or at

5 RTOG Update: RTOG Semiannual Meeting Materials Available on Web: The RTOG semiannual meeting will be held June 16 19, 2011 at the Loews Philadelphia Hotel in Philadelphia, PA. Hotel reservations must be made by May 26th to ensure availability. Register at the RTOG website: RTOG 0848, A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma, released Amendment 3 on May 23, 2011 and was broadcasted by RTOG on June 14, RTOG 0848 was amended as follows: The mandatory tumor tissue block and blood collection requirement has been revised to no longer be an eligibility criteria, however it is still a required submission prior to start of treatment. RTOG 1016, Phase III Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer, was activated on June 9, Let us know if your site is interested in participating. RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer, was updated for implementation of CTSU's Oncology Patient Enrollment Network (OPEN), the web-based registration system for patient enrollments on NCI-sponsored cooperative group clinical trials. OPEN provides the ability to enroll patients on a 24/7 basis. Effective June 3, 2011 at 8:30 a.m. EST, sites will use the OPEN Registration System to enroll new patients. Please contact Joshua Schoppe with any RTOG related issues.

6 Jefferson Oncology Group (JOG) Update: If your site has any JOG inquiries please contact either Joshua 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: RTOG Semiannual Meeting, Philadelphia, PA: June CRA Quarterly Meeting, Philadelphia, PA: 10-11am on June 22- Virtual Meeting: dial information attached in a separate document. CRA Quarterly Meeting, Philadelphia, PA: September 14 ECOG Semiannual Meeting, Hollywood, FL: November 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 Joshua.schoppe@jeffersonhospital.org