Priority Lists
Protocol Posting of
Activations
Activation - Effective 7/1/12
A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-Cell Lymphoma.
| Action Codes | FBR |
| Study Coordinator(s) | Nimish Mohile, M.D. |
| Participants | CTSU |
Closures
Permanent Closure
A Phase II Study of Epratuzumab in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Precursor B-cell Acute Lymphoblastic Leukemia
| Action Codes | ER |
| Study Coordinator(s) | Anjali S. Advani, M.D., Steven E. Coutre, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
| Closure Date | 2012-07-01 |
Amendments, Revisions, Memoranda
Memorandum - Patient Survey Gift Cards
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
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 |
Memorandum - Everolimus Expiration
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
| Action Codes | ER |
| Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - CC-5013 Safety Reports
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 - Everolimus Expiration
A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)
| Action Codes | ER |
| Study Coordinator(s) | Sai-Hong Ignatius Ou, M.D., Ph.D, Linda L. Garland, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates |
Memorandum - CC-5013 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 | 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 - AVE0005 Safety Report
A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
| Action Codes | ER |
| Study Coordinator(s) | Jeffrey W. Allen, M.D., Karen Kelly, M.D., Philip C. Mack, Ph.D., Shirish M. Gadgeel, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #3
Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel plus Vandetanib in Patients with Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
| Action Codes | ER |
| Study Coordinator(s) | Robert L. Coleman, M.D., Anil K. Sood, M.D. |
| Participants | Members, Affiliates, NCORP, Medical Oncologists |
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 |
Revision #4
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
| Action Codes | ER |
| Study Coordinator(s) | Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Web-Based Patient Information Page
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 |
Revision #2
Randomized Trial Of A Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Alfred Neugut, M.D., Dawn Hershman, M.D., M.S., Lisa Sparks, Ph.D, |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #3
Phase II Trial of the Aurora Kinase A Inhibitor, MLN8237, in Peripheral T-Cell Non-Hodgkin Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Paul M. Barr, M.D., Jonathan W. Friedberg, M.D., Daruka Mahadevan, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, CTSU |
Memorandum - CC-5013 Safety Reports
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 | AC, ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Revision #2
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 | AC, ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Revision #2
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 |
Memorandum-Protocol Completion & Change in Drug Supply
Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
| Action Codes | IP, ER |
| Study Coordinator(s) | Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG |
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