Priority Lists
Protocol Posting of
Activations
Activation - Effective 4/19/19
Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
| Action Codes | FBR |
| Study Coordinator(s) | Parminder Singh, M.D., Seth P. Lerner, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CCTG |
Closures
Amendments, Revisions, Memoranda
Memorandum - S1800A Training Webinar
A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
| Action Codes | NR |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Funding Memo (revised 4/9/19)
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
| Action Codes | NR |
| Study Coordinator(s) | Jason A. Zell, D.O. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Updated Funding Memorandum (Version Date: 04/01/2019)
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
| Action Codes | NR |
| Study Coordinator(s) | Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph |
| Participants | CTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP |
Memorandum - Spanish Translated Consent for Revision #11 (Version 3/14/19)
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)
| Action Codes | IP, AC, CBR, ER |
| Study Coordinator(s) | Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Corrected Version Date to 03/27/19 from Previous Funding Memo (03/04/19)
A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
| Action Codes | NR |
| Study Coordinator(s) | Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D. |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Revision #3 (Version Date 3/19/19)
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Robert S. Svatek, M.D., Ajjai S. Alva, M.D., Seth P. Lerner, M.D., Joshua Meeks, M.D., Scott Gilbert, M.D., Rick Bangs |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum - Updated Funding Memo (Version 4/12/19)
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Peter C.V. Black, M.D., Parminder Singh, M.D., Seth P. Lerner, M.D., David J. McConkey, Ph.D., Rick Bangs |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG, CCTG |
Memorandum- Updated Spanish-translated Model Consent Form (Version Date: 03/18/19)
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Revision #2 - Version Date 03/13/19
A Randomized Phase II Study of Pertuzumab and Trastuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER2 Amplification
| Action Codes | ER |
| Study Coordinator(s) | Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D. |
| Participants | CTSU Institutions in the United States |
Memorandum - S1613 Drug Order Form Update
A Randomized Phase II Study of Pertuzumab and Trastuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER2 Amplification
| Action Codes | ER |
| Study Coordinator(s) | Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D. |
| Participants | CTSU Institutions in the United States |
Memorandum - Master Forms Set Update
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
| Action Codes | NR |
| Study Coordinator(s) | Brian Chapin, M.D., Ana Aparicio, M.D., Amir Goldkorn, M.D., Richard Valicenti, M.D., John Gore, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Master Form Set Update
A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA 1/2 MUTATION STAGE IV NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
| Action Codes | ER |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #1 - Version Date 3/19/19
A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA 1/2 MUTATION STAGE IV NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
| Action Codes | ER |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required