Trial & Business Updates:

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Priority Lists

Activations

CTSU/A071401Phase II Intergroup

Activated - Effective 1/1/2016

Phase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 Mutations
Action CodesER
Study Coordinator(s)David E. Piccioni, MD, PhD
S1400Phase II-III Intergroup

S1400I Activation - 12/18/2015

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, CBR, FBR, ER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG

Closures

CTSU/N107CPhase III

Permanent Closure - Effective 12/18/15

A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Action CodesER
Study Coordinator(s)Laurie E. Gaspar, M.D.
ParticipantsCTSU
Closure Date2015-12-18
S1211Phase I-II

Temporary Closure, Effective 1/6/2016

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 CodesER
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1400Phase II-III Intergroup

S1400A Permanent Closure to accrual - effective 12/18/2015

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, CBR, FBR, ER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG

Amendments, Revisions, Memoranda

S1211Phase I-II

Memorandum - Holiday Closure

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 CodesER
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1216Phase III

Memorandum - Lab Holiday Closure

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Action CodesNR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY
S1400Phase II-III Intergroup

Revision #3

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, CBR, FBR, ER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1403Phase II-III

Revision #2

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 CodesAC, ER
Study Coordinator(s)Sarah B. Goldberg, MD, MPH, Rogerio C. Lilenbaum, M.D., Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - Webinar Information

A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
Action CodesNR
Study Coordinator(s)Scott Ramsey, M.D., Dawn Hershman, M.D., M.S., Gary Lyman, M.D., Sean Sullivan, Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
  • 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