MINORITY/UNDERSERVED NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM
Use of a Clinical Screening Tool to Address Cancer Health Disparities in the NCI Community
Oncology Research Program (NCORP)
Target: n/a Total: 2374
SPECIMEN COLLECTION AUGUSTA UNIVERSITY
Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate,
Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse
Populations
AUGUSTA UNIVERSITY
Patient-derived Models Tissue Procurement Protocol for the National Cancer Institute
MOLECULAR ANALYSIS FOR THERAPY CHOICE (MATCH)
Solid tumors/lymphoma that has progressed following at least one line of standard
systemic therapy and/or for whose disease no standard treatment exists that has been
shown to prolong survival.
Screening Target: 6452 Screening Total: 6507
Intervention Target: 1425 Intervention Total: 778
BREAST PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life
of Women with Breast Cancer
Target: 317 Total: 221
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
Alternate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast
Cancer NeoAdjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
Target: 1475 Total: 1113
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary
Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node
Disease After Neoadjuvant Chemotherapy
ATHENS & DEKALB MEDICAL
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment
of Overweight and Obese Women with Early Breast Cancer
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant
Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
ATHENS & DEKALB MEDICAL
A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation
in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant
Chemotherapy
ATHENS & DEKALB MEDICAL
A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal
Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
ATHENS, DEKALB MEDICAL & PHOEBE CANCER CENTER
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide
Followed by Weekly Paclitaxel with or Without Carboplatin for Node-Positive or High-Risk
Node-Negative Triple-Negative Invasive Breast Cancer
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional
Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary
Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary
Nodes After Neoadjuvant Chemotherapy
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase
III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant
Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative
Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant
or Adjuvant Chemotherapy.
AUGUSTA UNIVERSITY, ATHENS, DEKALB MEDICAL & PHOEBE CANCER CENTER
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. e^3 Breast Cancer Study-Evaluating Everolimus
with Endocrine Therapy.
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888
(Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated
Breast Cancer
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized, Phase III Trial to Evaluate the 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
Target: 1000 Total: 171
GYNECOLOGICAL PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY
A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin
in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
Target: 210 Total: 132
AUGUSTA UNIVERSITY
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide,
and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal
Tumors of the Ovary.
Target: 128 Total: 49
AUGUSTA UNIVERSITY
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327)
Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally
Advanced Squamous Cell Carcinoma of the Vulva
Target: 52 Total: 36
AUGUSTA UNIVERSITY & DEKALB MEDICAL
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment
for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK
Trial.
Target: 285 Total: 171
AUGUSTA UNIVERSITY
A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination
with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II,
IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer
Target: 188 Total: 97
AUGUSTA UNIVERSITY
A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy
in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal
Cancer
Target: 147 Total: 17
AUGUSTA UNIVERSITY & DEKALB MEDICAL
A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied
Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied
Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant
Ovarian Cancer
Target: 488 Total: 32
GYNECOLOGICAL PENDING PROTOCOLS
AUGUSTA UNIVERSITY
Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab
and Paclitaxel Treatment of Platinum-Resistant Persistent or Recurrent Epithelial
Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Target: 184 Total: 0
GYNECOLOGICL PREVENTION PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY, DEKALB MEDICAL & MOOREHOUSE
Can Diet and Physical Activity Modulate Ovarian Fallopian Tube and Primary Peritoneal
Cancer Progression-Free Survival?”
Target: 1150 Total: 1129
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
(EROS) Engendering Reproductive Health within Oncologic Survivorship
Target: 612 Total: 179
BRAIN
ATHENS
Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton
Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant
Temozolomide in Patients With Newly Diagnosed Glioblastoma
Target: 576 Total: 310
ATHENS
Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo
(BeSt) for Radionecrosis after Radiosurgery for Brain Metastases
Target: 130 Total: 14
HEAD AND NECK PROTOCOL OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
Temporarily Closed to Accrual
Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with
Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk
Squamous Cell Cancer of the Head and Neck
Target: 660 Total: 204
ADULT LEUKEMIA PENDING PROTOCOLS
ADULT LEUKEMIA PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic
Leukemia (APL)
Target: 200 Total: 25
LYMPHOMA PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY
A randomized double-blind phase III study of ibrutinib during and following autologous
stem cell transplantation versus placebo in patients with relapsed or refractory diffuse
large B-Cell lymphoma of the activated B-Cell subtype
Target: 302 Total: 24
Target: 689 Total: 17
LUNG PROTOCOLS OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY, ATHENS, DEKALB MEDICAL & PHOEBE CANCER CENTER
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous
Cell Lung Cancer
Target: 10000 Total: 1592
ALCHEMIST
AUGUSTA UNIVERSITY, ATHENS, DEKALB MEDICAL & PHOEBE CANCER CENTER
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
Target: 8300 Total: 3046
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients
with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small
Cell Lung Cancer (NSCLC)
Target: 450 Total: 194
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell
Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic
Lymphoma Kinase (ALK) Fusion Protein
Target: 378 Total: 61
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of
Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung
Cancers
Target: 714 Total: 338
PENDING LUNG PROTOCOLS
AUGUSTA UNIVERSITY & DEKALB MEDICAL
A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib
Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non-Squamous NSCLC
Target: 169 Total: 0
OPEN MELANOMA PROTOCOLS
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab
at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression
in Patients with Advanced BRAFV600 Mutant Melanoma
Target: 300 Total: 140
AUGUSTA UNIVERSITY, ATHENS & DEKALB MEDICAL
Temporarily Closed
Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus
Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Target: 400 Total: 250
GASTROINTESTINAL
ATHENS
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Target: 148 Total: 39
PREVENTION PROTOCOL OPEN TO ENROLLMENT
AUGUSTA UNIVERSITY
The Caucasian/other races cohort is closed to accrual
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal
Symptoms (AIMSS)
Target: 1000 Total: 1006
CCDR PROTOCOLS
AUGUSTA UNIVERSITY
Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Target: 172 Total: 48
AUGUSTA UNIVERSITY
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)
Target: 3960 Total: 1632
CCDR PROTOCOLS PENDING
PEDIATRIC PROTOCOLS OPEN TO ENROLLMENT (AU)
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Target: 17230 Total: 16078
Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia
(B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Target: 5872 Total: 8906
Temporarily Closed
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia
(B-ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
Target: 5437 Total: 5031
Temporarily Closed
A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on
a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia
(T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)
Target: 1400 Total: 832
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed
Ependymoma Ages 1 to 21 Years: A Groupwide Phase III Study
Target: 400 Total: 399
Key Adverse Events After Childhood Cancer
Target: 8100 Total: 3482
Utilizing Response- and Biology-Based Risk Factors to Guide Therapy
Target: 621 Total: 198
Neuroblastoma Biology Studies
Target: 10,000 Total: 9869
Renal Tumors Classification, Biology and Banking Study
Banking
Total: 5987
Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS):
A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation
Plus or Minus Pazopanib
Target: 340 Total: 115
