Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure - Step 2 Registration, Effective 11/30/17
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
| Action Codes | ER |
| Study Coordinator(s) | Daniel O. Persky, M.D. |
| Participants | NCORP, Affiliates, CTSU, Members |
Temporary Closure - Effective 6/26/18
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 | ER, NR |
| 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 |
Partial Temporary Closure (Cohort 12) - Effective 7/5/18
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | NR |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Partial Permanent Closure (Cohort 31) - Effective 6/27/18
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | NR |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Amendments, Revisions, Memoranda
Revision #10 – Version Date 6/1/18
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Rita S. Mehta, M.D., Kathy Albain, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
Memorandum - CC-5013 (Lenalidomide) Safety Reports
A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
| Action Codes | IP, ER |
| Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Revision #25 - Version Date 5/15/18
A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
| Action Codes | IP, ER |
| Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Memorandum - Lenalidomide Safety Report
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
| Action Codes | IP, AC, ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Revision #14 - Version Date 5/15/18
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
| Action Codes | IP, AC, ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Memorandum - ABT-888 Safety Report
A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
| Action Codes | ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Revision #12 - Version Date 5/15/18
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
| Action Codes | IP, ER |
| Study Coordinator(s) | Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD |
| Participants | Limited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - CC-5013 (Lenalidomide) Safety Reports
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
| Action Codes | IP, ER |
| Study Coordinator(s) | Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD |
| Participants | Limited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - Kuhn Laboratory Relocation (Lab #209)
Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial In Postmenopausal Patients With Hormone-Receptor Positive Stage IV Breast Cancer.
| Action Codes | NR |
| Study Coordinator(s) | George Somlo, M.D., Halle C.F. Moore, M.D., Daniel F. Hayes, M.D. |
| Participants | NCORP, Affiliates, Members, Medical Oncologists, Surgeons |
Memorandum 1 of 2 - GDC-0032 Safety Report (for S1400B)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | AC, ER, NR |
Memorandum 2 of 2 - Site Coordinators Committee, Sub-Study Options, S1400K Form
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | AC, ER, NR |
Revision #19 (S1400K) - Version Date 4/18/18
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | AC, ER, NR |
Memorandum - Master Forms Set Updated
A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High-Risk Resected Melanoma
| Action Codes | NR |
| Study Coordinator(s) | Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - ABT-888 Safety Report
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases
| Action Codes | ER, NR |
| Study Coordinator(s) | Eve Rodler, M.D., Priyanka Sharma, M.D., Julie R. Gralow, M.D. |
| Participants | CTSU |
Memorandum 1 of 2 - Kuhn Laboratory Relocation (Lab #209)
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases
| Action Codes | ER, NR |
| Study Coordinator(s) | Eve Rodler, M.D., Priyanka Sharma, M.D., Julie R. Gralow, M.D. |
| Participants | CTSU |
Memorandum - Updated DTL
A Randomized Phase III Trial to Evaluate Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/=1 CM Residual Invasive Cancer or Positive Lymph Nodes (>ypN+) After Neoadjuvant Chemotherapy.
| Action Codes | NR |
| Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Master Forms Set Updated
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 |
Memorandum - Velaparib Safety Report
Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC- 737664) in Metastatic Pancreatic Cancer
| Action Codes | ER |
| Study Coordinator(s) | E. Gabriela Chiorean, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum – Master Forms Set Updated
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 | ER, NR |
| 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 |
Revision #2 - Version Date 05/22/18
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - CC-5013 (Lenalidomide) Safety Report
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - CC-5013 (Lenalidomide) Safety Report
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - Updated Master Forms Set
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | NR |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Updated Forms Set
A Randomized Phase II/III Trial of "Novel Therapeutics" versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
| Action Codes | NR |
| Study Coordinator(s) | Laura Michaelis, MD, Roland Walter, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Pertuzumab Safety Report
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 2 of 2 - Trastuzumab Safety Report
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 |
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