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Clinical Trials

Active Trials

Dayton Clinical Oncology Program accesses clinical trials through its membership in cooperative research groups funded by the National Cancer Institute (NCI), and through the pharmaceutical industry.

For more infomation about any of the trials listed below
ask your doctor or search www.clinical trials.gov

Cancer Control

General Cancer Control Protocols for Symptom Management

  • A221602-Olanzapine With Or Without Fosaprepitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double-Blind, Placebo-Controlled Trial (NCT03578081)
  • AFT-28 - Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)(NCT02744092)
  • NRG-CC004 - A Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer.(NCT03180294)

Trials descriptions available on http://www.clinicaltrials.gov

Brain 

Glioblastoma / Meningioma 

  • A071401 - Trial Of SMO/AKT/Nf2 Inhibitors In Progressive Meningiomas With SMO/AKT/Nf2 Mutations (NCT02523014)

Trials descriptions available on http://www.clinicaltrials.gov

Breast

Cancer Control / HER2- / BRACA+/ Triple Negative
Metastatic / Nodal 


  • A011106- ALTernate approaches for Clinical Stage II or III Estrogen Receptor positive breast cancer Neo Adjuvant TrEatment (ALTERNATE) in postmenopausel women: a Phase III Study (NCT01953588)
  • A011401 - Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (NCT02750826)
  • A011502-A randomized phase III double blinded placebo-controlled trial of aspirin as adjuvant therapy HER2 negative breast cancer: the ABC trial (NCT02927249)
  • A221405-A Study Evaluating The Pregnancy Outcomes And Safety Of Interrupting Endocrine Therapy For Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy (Positive)(NCT02308085)
  • EA1131-A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy(NCT02445391)
  • FB-12-An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)(NCT03412643)
  • NRG-BR002 - Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer (NCT02364557)
  • NRG-BR003 - 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(NCT02488967)
  • NSABP B-51 - 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 (NCT01872975)
  • S1416 - Trial of Cisplatin with or without Veliparib in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer (NCT02595905)
  • S1418 - Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative BreastCancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy (NCT02954874)
  • S1501- Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III (NCT03418961)

  • S1703 - Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer (NCT03723928)

  • S1706-A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy alone for Inflammatory Breast Cancer,” (NCT03598257)
  • URCC-16070 - Treatment of Refractory Nausea (NCT03367572)
  • WF97116 - Trial Of Donepezil In Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment (NCT02822573)


Trials descriptions available on http://www.clinicaltrials.gov

Gastrointestinal

Cancer control / Colorectal / Liver / Pancreatic

  • A021502 - Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT02912559)
  • EA2142 - Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas (NCT02595424)
  • EA2161- Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)(NCT02893930)

  • NRG-GI002 - A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer (NCT02921256)

  • NRG-GI004 - Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer (NCT02997228)
  • RTOG-1112 - Randomized Phase III Study of Sorafenib versus Stereotactic Body Radiation Therapy followed by Sorafenib in Hepatocellular Carcinoma (NCT01730937)
  • S0820 - Double-blind Placebo-controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers for Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES) (NCT01730937)

  • S1613 - Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification (NCT03365882)
  • S1815-A Phase III Randomized Trial Of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed Advanced Biliary Tract Cancers (NCT03768414)

  • URCC-16092 - Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy (NCT03186638)

Trials descriptions available on http://www.clinicaltrials.gov

Genitournary

Bladder / Prostate / Renal / Urothelial

  • A031501 - Phase III randomized “Adjuvant study of MK-3475 (pembrolizumab) in muScle invaSive and locally ADvanced urOthelial caRcinoma” (AMBASSADOR) versus observation (NCT03244384)
  • A031701 - A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations (NCT03609216)
  • AFT-19 - A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (NCT03009981)
  • EA8143 - Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)(NCT03055013)
  • EA8153 - Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial (NCT03419234)
  • NRG-GU002 - Trial Of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or without Adjuvant Docetaxel (NCT03070886)
  • NRG-GU006 - A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial Of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer. (NCT03371719)
  • S1500 - Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511}) in Metastatic Papillary Renal Carcinoma (PAPMET) (NCT02761057)
  • S1602 - Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer (NCT03091660)
  • S1605 - Trial of Atezolizumab in BCG-UnresponsiveNon-Muscle Invasive Bladder Cancer (NCT02844816)
  • S1802-Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer (NCT03678025)

Trials descriptions available on http://www.clinicaltrials.gov

GYN

Uterine / Ovarian / Endometrial

  • GOG-0238 - Trial Of Pelvic Irradiation With Or Without Concurrent Weekly Cisplatin In Patients With Pelvic-Only Recurrence Of Carcinoma Of The Uterine Corpus (NCT00492778)
  • NRG-GY005 - Study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)(NCT02502266)
  • NRG-GY006 - 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.(NCT02466971)

  • NRG-GY007 - 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 (IND 129988)(NCT02713386)

  • NRG-GY009 - Study of Pegylated Lipsomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer (NCT02839707)
  • NRG-GY012 - A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS) (NCT03660826)
  • NRG-GY014- A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma (NCT03348631)
  • NRG-GY016-A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary. (NCT03602586)

Trials descriptions available on http://www.clinicaltrials.gov

Head & Neck

  • EA3132 - Adjuvant Radiotherapy with or without Cisplatin for P53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)(NCT02734537)

Trials descriptions available on http://www.clinicaltrials.gov

Leukemia

ALL / AML / CML

  • A041702-A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL) (NCT03737981)
  • E1910 - Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults (NCT02003222)
  • EA9161-A Randomized Phase II/III Trial of “Novel Therapeutics” versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older (NCT03092674)
  • S1612 - A Randomized Phase II/III Trial of “Novel Therapeutics” versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older (NCT03092674)

Trials descriptions available on http://www.clinicaltrials.gov

Lung

NSCLC / SCLC / Squamous Cell

  • A081105 - (ALCHEMIST) Study Of Erlotinib Or Placebo In Patients With Completely Resected Epidermal Growth Factor Receptor (EGRF) Mutant Non-Small Cell Lung Cancer (NSCLC)(NCT02193282)
  • A151216 - (ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (NCT02194738)
  • A211401- Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes (NCT02856581)
  • A221504-A Randomized, Double-Blind, Placebo-Controlled Pilot Study Of An Oral, Selective Peripheral Opioid Receptor Antagonist In Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)(NCT03087708)
  • E4512 - (ALCHEMIST) 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 (NCT02201992)
  • EA5142 - (ALCHEMIST) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers (NCT02595944)
  • EA5152 - A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non- Squamous NSCLC (NCT03468985)
  • EA5162 - Phase II Study of Osimer1nib in Advanced NSCLC Pa1ents with Exon 20 Muta1ons in EGFR (NCT03191149)
  • LUNGMAP-A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study) (NCT02154490)
  • NRG-CC003 - Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer (NCT02635009)
  • NRG-LU002 - Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial (NCT03137771)
  • NRG-LU003-A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Master Protocol (NCT03737994)
  • S1400F - A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTI-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)(NCT03373760)
  • S1900A-A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)(NCT03845296)

Trials descriptions available on http://www.clinicaltrials.gov

Lymphoma

Mantle Cell / Refractory


  • S1608 - Trial in Early Relapsing or Refractory Follicular Lymphoma.(NCT03269669)

Trials descriptions available on http://www.clinicaltrials.gov

Melanoma

Advanced / Refractory / BRAFV600 Mutant

  • EA6134 - 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 (NCT02224781)
  • EA6141- Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma (NCT02339571)
  • S1320 - Trial Of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) And Trametinib (NSC-763093) In BRAF V600E/K Mutant Melanoma(NCT02196181)
  • S1607 - Study of Combining Talimogene Laherparepvec (T-VEC) (NSC-785349) and MK-3475 (pembrolizumab) (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy (NCT02965716)
  • S1616 - Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1Agent. (NCT03033576)
  • S1801-A Phase II Randomized Study of Adjuvant vs. Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma (NCT03698019)

Trials descriptions available on http://www.clinicaltrials.gov

Myeloma

  • There are no Myeloma trials available at our sites at this time.

Trials descriptions available on http://www.clinicaltrials.gov

Other

  • A031102 - Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors (NCT02375204)

  • EAY131- Molecular Analysis for Therapy Choice (MATCH) (NCT02465060)

  • S1609 - DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (NCT02834013)
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