Priority Lists
Protocol Posting of
Activations
Activation Effective 5/15/13
Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients with Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study
| Action Codes | FBR |
| Study Coordinator(s) | Syed Ahmad, M.D. |
| Participants | CTSU, Limited: Institutions Listed on the Title Page |
Activation Effective 5/15/13
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor (AI)-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer
| Study Coordinator(s) | Norah L. Henry, M.D.,Ph.D., Anne F. Schott, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Closures
Permanent Closure - effective 6/1/2013
A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
| Action Codes | ER, NR |
| Study Coordinator(s) | Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | NCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU |
Amendments, Revisions, Memoranda
Memorandum - Veridex Holiday Closure
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
| Action Codes | NR |
| Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Revision #12
A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
| Action Codes | ER, NR |
| Study Coordinator(s) | Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | NCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU |
Memorandum - CC-5013 Safety Report
A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
| Action Codes | ER |
| Study Coordinator(s) | Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - CC-5013 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 - MK-2206 Safety Report
A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
| Action Codes | ER |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D. |
| Participants | Medical Oncologists, Members, NCORP, Affiliates |
Memorandum - Master Forms Set Update
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 | NR |
| 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 |
Memorandum - MK-2206 Safety Report
Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
| Action Codes | ER |
| Study Coordinator(s) | Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum 1 of 2 - CC-5013 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 2 of 2 - Revision #3 Cover Memo Correction
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 - Forms Updates
A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
| Action Codes | NR |
| Study Coordinator(s) | Guillermo Garcia-Manero, M.D., Jerald P. Radich, M.D., Min Fang, M.D.,Ph.D., John Pagel, MD, PhD |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Memorandum - ABT-888 Safety Reports
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 | AC, ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Revision #1
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 | AC, ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Revision #6
Long Term Follow-Up Protocol: An Administrative Tool.
| Action Codes | NR |
| Participants | Members, NCORP, UCOP |
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