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Gastrointestinal Clinical Trials

With an emphasis on transdisciplinary translational research, the OSUCCC-James facilitates investigator-initiated early phase clinical trials and participates in many cooperative groups.


Protocol No.PITitle
OSU-10150Mark ArnoldA prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint
CALGB-71002Tony Bekaii-SaabEmbedded Companion to CALGB-80702
OSU-11147Tony Bekaii-SaabA Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Versus Placebo With FOLFIRI as Second-Line Therapy in Patients with Metastatic Colorectal Cancer
CALGB-580901Tony Bekaii-SaabEmbedded Companion to CALGB 80802
CALGB-150902Tony Bekaii-SaabEmbedded Companion to CALGB 80802
CALGB-60901Tony Bekaii-SaabEmbedded Companion Study to CALGB 80802
OSU-10045Tony Bekaii-SaabA 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel plus Reovirus Serotype-3 Dearing Strain (Reolysin®) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients with Recurrent or Metastatic Pancreatic Cancer
CALGB-80702Tony Bekaii-SaabA Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
CALGB-150911Tony Bekaii-SaabEmbedded Protocol to CALGB-80702
CALGB-60905Tony Bekaii-SaabEmbedded Protocol to CALGB-80702
CALGB-580601Tony Bekaii-SaabEmbedded companion to CALGB 80302:
CALGB-60601Tony Bekaii-SaabEmbedded Companion to CALGB 80403: Pharmacogenomic companion in CALGB 80403.
CALGB-70502Tony Bekaii-SaabEmbedded Companion Study to CALGB 80405
CALGB-150506Tony Bekaii-SaabEmbedded Companion Study to CALGB 80405
CALGB-60501Tony Bekaii-SaabEmbedded Companion to CALGB 80405
OSU-08078Tony Bekaii-SaabA prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumor in first line medical treatment
OSU-09138Tony Bekaii-SaabPhase I Active Immunotherapy Trial with a combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cells Peptide Vaccine emulsified in ISA 720 and nor-MDP Adjuvant in Patients with Advanced Solid Tumors
CALGB-80802Tony Bekaii-SaabA Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib Alone In Patients with Advanced Hepatocellular Carcinoma (HCC).
OSU-10034Tony Bekaii-SaabA Phase III Study of Chemotherapy and Chemoradiotherapy with or without HyperAcute Pancreatic Cancer Vaccine in Subjects with Surgically Resected Pancreatic Cancer.
CALGB-71003Tony Bekaii-SaabEmbedded Companion to CALGB-80803
CALGB-151007Tony Bekaii-SaabEmbedded Companion to CALGB-80803
SWOG-S1201Tony Bekaii-Saab"A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross- Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
OSU-12136Tony Bekaii-SaabNAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin versus 5-Flourouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer Who have Failed Prior Gemcitabine-based Therapy
CALGB-80803Tony Bekaii-SaabRANDOMIZED PHASE II TRIAL OF PET SCAN-DIRECTED COMBINED MODALITY THERAPY IN ESOPHAGEAL CANCER
OSU-10110P. Mark BloomstonCytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
OSU-11157P. Mark BloomstonA Phase 1/2a Dose-escalation Study of JX-594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Followed by Intratumoral (IT) Boosts Alone and in Combination with Irinotecan in Patients with Metastatic, Refractory Colorectal Carcinoma
OSU-11113P. Mark BloomstonA Randomized Prospective Multicenter Trial of Pancreas Resection with and without Routine Intraperitoneal Drainage
OSU-07013Albert de la ChapelleThe Identification of Predisposing Genes in Hyperplastic Polyposis (HPP)
OSU-11182Richard GoldbergA Phase II Study of the Combination of Aflibercept (VEGF-Trap) plus Modified FOLFOX 6 in Patients with Previously Untreated Metastatic Colorectal Cancer
OSU-12170Heather HampelThe Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome
OSU-13014James HanjePre-chemotherapy hepatitis B screening and treatment reduces mortality related to hepatitis B reactivation In patients receiving chemotherapy
OSU-07104Mira KatzPatient Activation to Increase Colorectal Cancer Screening
OSU-05060Kimberly KellySurvey of PCP's Comfort with Management of HBOC and HNPCC.
OSU-05109Kari KendraScreening Patients for Clinical Trials.
OSU-10036Hooman KhabiriA Humanitarian Device Exemption Treatment Protcol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
OSU-06002Greg LesinskiA Storage Facility for Peripheral Blood Obtained from Patients with Gastrointestinal Malignancies.
OSU-08028Ryan NiederkohrRetrospective Evaluation of the Accuracy of PET/CT with Respect to Surgiscal Planning in Patients with Colorectal Cancer
OSU-08073Electra PaskettEnhancing Colorectal Cancer Screening in Primary Care: (TIME-Teaching Interventions to Educate and Motivate)
OSU-08168Electra PaskettCBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia
OSU-10025Stephen PovoskiRestrospective Evaluation of Patients Undergoing Surgery and Same-Day Intravenous Administration of 18F-FDG
OSU-09123David RentonSingle Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
ECOG-1208Carl Schmidt A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HHC) in Patients with and without Vascular Invasion
NCCTG-N1048Carl Schmidt A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision.
RTOG-1112Terence WilliamsRandomized Phase III Study of Sorafenib versus Stereotactic Body Radiation Therapy followed by Sorafenib in Hepatocellular Carcinoma
OSU-11131Christina WuA PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH FOLFIRI AFTER PROGRESSION ON FOLFIRI PLUS BEVACIZUMAB IN KRAS WILD TYPE METASTATIC COLORECTAL CANCER.
OSU-12054Evan WuthrickA phase I trial of MEK inhibitor GSK1120212 in combination with neoadjuvant 5-Fluorouracil chemoradiation in the treatment of KRAS, BRAF, and NRAS-mutant rectal cancers
RTOG-1010Evan WuthrickA Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-overexpressing Esophageal Adenocarcinoma