Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure (Step 1)-Effective 2/15/2017
A Phase III Surgical Trial to Evaluate The Benefit Of A Standard Versus An Extended Pelvic Lymphadenectomy Performed At Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
| Action Codes | ER |
| Study Coordinator(s) | Seth P. Lerner, M.D., Theresa M. Koppie, M.D., Ajjai S. Alva, M.D., Robert S. Svatek, M.D., Sumanta K. Pal, M.D., Francisco G. LaRosa, M.D., Rick Bangs |
| Participants | Limited: Credentialed Surgeons Listed on S1011 Abstract Page |
| Closure Date | 2017-04-15 |
Permanent Closure – Effective 02/15/17
Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S. |
| Participants | Limited: Institutions Listed on the Title Page |
Permanent Closure – Effective 02/15/17
A Sero-Epidemiologic Survey and Cost-effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
| Action Codes | NR |
| Study Coordinator(s) | Scott Ramsey, M.D. |
| Participants | SWOG, NCORP, Affiliates, Medical Oncologists |
| Closure Date | 2017-02-15 |
Amendments, Revisions, Memoranda
Memorandum - Fulvestrant Safety Report
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
| Action Codes | ER |
| Study Coordinator(s) | Rita S. Mehta, M.D., Kathy Albain, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
Memorandum 1 of 2 - Bortezomib (PS-341) Safety Report
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 | 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 2 of 2 - CC-5013 (Lenalidomide) Safety Report
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 | 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-Abiraterone Acetate Safety Reports
Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
| Action Codes | ER |
| Study Coordinator(s) | Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Memorandum - CC-5013 (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 | ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Memorandum-Mouthwash Recommendation
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 1 of 2 - Bortezomib (PS-341) Safety Report
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 | 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 2 of 2 - CC-5013 (Lenalidomide) Safety Report
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 | 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-Fulvestrant Safety Report
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 | ER |
| 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 - PEGPH20 Safety Report
A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
| Action Codes | ER |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - 2 Slots Available in Cohort 2
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 5 - MEDI4736 Safety Reports (for S1400A)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 2 of 5 - Palbociclib Safety Reports (for S1400C)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 3 of 5 - S1400I PRO Error
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 4 of 5 - Ipilimumab Safety Reports (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 5 of 5 - Nivolumab Safety Reports (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum-Afatinib Safety Report
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone In Treatment-Naïve Patients With Advanced, EGFR Mutation Positive Non-Small Lung Cancer (NSCLC)
| Action Codes | ER |
| Study Coordinator(s) | Sarah B. Goldberg, MD, MPH, Rogerio C. Lilenbaum, M.D., Katerina Politi, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Vemurafenib Expiration
Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
| Action Codes | NR |
| Study Coordinator(s) | E. Scott Kopetz, M.D., Heinz- Josef Lenz, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum-BAHO Forms and Specimen Submission
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 |
Memorandum - Approval of Spanish Consent Form for Revision #2
A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
| Action Codes | NR |
| Study Coordinator(s) | Davendra Sohal, MD, MPH, Syed Ahmad, M.D., Philip A. Philip, M.D.,Ph.D., Andrew M. Lowy, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Ipilimumab (BMS-734016) Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | ER |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 2 of 2 - Nivolumab (BMS-936558) Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | ER |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
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