Esophageal Diseases News

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||||||||||  cisplatin / Generic mfg., paclitaxel / Generic mfg.
Trial completion, Surgery:  Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach (clinicaltrials.gov) -  Feb 19, 2014
P2, N=55, Completed,  Sponsor: Eastern Cooperative Oncology Group
Active, not recruiting --> Completed

||||||||||  Leukine (sargramostim) / Partner Therap
Trial completion, Metastases:  Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors (clinicaltrials.gov) -  Feb 19, 2014
P2, N=24, Completed,  Sponsor: Georgetown University
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Genasense (oblimersen) / Genta
Trial completion, Metastases:  Chemotherapy in Treating Patients With Solid Tumors (clinicaltrials.gov) -  Feb 19, 2014
P1/2, N=57, Completed,  Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  cisplatin / Generic mfg., paclitaxel / Generic mfg.
Trial completion, Surgery:  Combination Chemotherapy, Radiation Therapy and Surgery in Treating Patients With Cancer of the Esophagus (clinicaltrials.gov) -  Feb 19, 2014
P2, N=25, Completed,  Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Eflornithine to Prevent Cancer in Patients With Barrett's Esophagus (clinicaltrials.gov) - Feb 19, 2014
P2b, N=152, Completed, Sponsor: University of Michigan Cancer Center
Active, not recruiting --> Completed No longer recruiting --> Completed

||||||||||  Photofrin (porfimer sodium) / Advanz Pharma
Trial completion:  Photodynamic Therapy in Treating Patients With Early Esophageal Cancer (clinicaltrials.gov) -  Feb 19, 2014
P2, N=30, Completed,  Sponsor: Roswell Park Cancer Institute
No longer recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion, Surgery, FDG PET: PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery (clinicaltrials.gov) - Feb 19, 2014
P2/3, N=75, Completed, Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  cisplatin / Generic mfg., paclitaxel / Generic mfg.
Trial completion:  Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus (clinicaltrials.gov) -  Feb 19, 2014
P1, N=24, Completed,  Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  isotretinoin / Generic mfg.
Trial completion:  Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer (clinicaltrials.gov) -  Feb 19, 2014
P2, N=0, Completed,  Sponsor: Hoag Memorial Hospital Presbyterian
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial initiation date, Metastases: ATTACK-OG: NY-ESO-1 T Cells in OG Cancer (clinicaltrials.gov) - Feb 19, 2014
P2, N=28, Not yet recruiting, Sponsor: Fiona Thistlethwaite
Active, not recruiting --> Completed Initiation date: Apr 2013 --> Apr 2014

||||||||||  PPC-5650 / PainCeptor
Trial completion:  A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus (clinicaltrials.gov) -  Feb 18, 2014
P1, N=25, Completed,  Sponsor: Asbj
Initiation date: Apr 2013 --> Apr 2014 Recruiting --> Completed

|||||||||| Enrollment change: Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (clinicaltrials.gov) - Feb 10, 2014
P2, N=24, Completed, Sponsor: EndoStim Inc.
Recruiting --> Completed N=30 --> 24

|||||||||| Trial completion: Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (clinicaltrials.gov) - Feb 10, 2014
P2, N=24, Completed, Sponsor: EndoStim Inc.
N=30 --> 24 Active, not recruiting --> Completed

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment change, Metastases:  Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer (clinicaltrials.gov) -  Feb 9, 2014
P1/2, N=43, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed N=55 --> 43

|||||||||| New P2 trial: Bethanechol for Eosinophilic Esophagitis (clinicaltrials.gov) - Feb 6, 2014
P2, N=40, Recruiting, Sponsor: University of Iowa

|||||||||| Trial completion: Endoscopic Detection of Dysplasia in Barrett's Esophagus (clinicaltrials.gov) - Feb 6, 2014
P=N/A, N=111, Completed, Sponsor: Göteborg University
N=55 --> 43 Recruiting --> Completed

||||||||||  Takecab (vonoprazan) / Takeda, Phathom Pharma
Trial completion:  A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis (clinicaltrials.gov) -  Feb 6, 2014
P3, N=19, Completed,  Sponsor: Takeda
Recruiting --> Completed Recruiting --> Completed

||||||||||  pemetrexed / Generic mfg., docetaxel / Generic mfg.
Enrollment closed, Combination therapy, Metastases:  Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Feb 5, 2014
P1, N=54, Active, not recruiting,  Sponsor: University of Arizona
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Estybon (rigosertib) / Onconova, SymBio Pharma, Knight Therap
Enrollment closed, Metastases:  Oral Rigosertib for Squamous Cell Carcinoma (clinicaltrials.gov) -  Feb 4, 2014
P2, N=80, Active, not recruiting,  Sponsor: Onconova Therapeutics, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Dexilant (dexlansoprazole) / Takeda
Enrollment closed, IO biomarker:  Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation? (clinicaltrials.gov) -  Feb 2, 2014
P4, N=60, Active, not recruiting,  Sponsor: Mayo Clinic
Recruiting --> Active, not recruiting Enrolling by invitation --> Active, not recruiting

|||||||||| Enrollment open: Proton Beam Therapy to Treat Esophageal Cancer (clinicaltrials.gov) - Jan 30, 2014
P=N/A, N=60, Recruiting, Sponsor: Washington University School of Medicine
Enrolling by invitation --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg., everolimus / Generic mfg.
Enrollment closed, Metastases:  Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer (clinicaltrials.gov) -  Jan 28, 2014
P1/2, N=44, Active, not recruiting,  Sponsor: City of Hope Medical Center
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Vectibix (panitumumab) / Amgen
Enrollment closed, Metastases:  Phase II Study of Irinotecan and Panitumumab (clinicaltrials.gov) -  Jan 28, 2014
P2, N=43, Active, not recruiting,  Sponsor: Weijing Sun, MD, FACP
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Biomarker, Trial initiation date: Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation (clinicaltrials.gov) - Jan 23, 2014
P=N/A, N=100, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting Initiation date: Dec 2013 --> Apr 2014

|||||||||| Trial initiation date: Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection (clinicaltrials.gov) - Jan 21, 2014
P=N/A, N=38, Completed, Sponsor: Medical University of Vienna
Initiation date: Dec 2013 --> Apr 2014 Initiation date: Jul 2010 --> Jul 2011

||||||||||  Dexilant (dexlansoprazole) / Takeda
Trial completion:  Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents (clinicaltrials.gov) -  Jan 21, 2014
P2, N=104, Completed,  Sponsor: Takeda
Initiation date: Jul 2010 --> Jul 2011 Recruiting --> Completed

|||||||||| Trial completion: Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection (clinicaltrials.gov) - Jan 21, 2014
P=N/A, N=38, Completed, Sponsor: Medical University of Vienna
Recruiting --> Completed Recruiting --> Completed

||||||||||  sorafenib / Generic mfg.
Trial completion:  Sorafenib. ICORG 06-41, V4 (clinicaltrials.gov) -  Jan 21, 2014
P2, N=54, Completed,  Sponsor: ICORG- All Ireland Cooperative Oncology Research Group
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  TheraCIM (nimotuzumab) / Daiichi Sankyo, Oncoscience, Biocon
New P2 trial, Surgery, Metastases:  Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus (clinicaltrials.gov) -  Jan 20, 2014
P2, N=40, Not yet recruiting,  Sponsor: Zhejiang University

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial termination, Surgery:  Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer (clinicaltrials.gov) -  Jan 16, 2014
P2, N=22, Terminated,  Sponsor: Eastern Cooperative Oncology Group
Suspended --> Terminated; The study used a two-stage design. After stage one, the study was terminated due to excess toxicity.

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment change, Surgery:  Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer (clinicaltrials.gov) -  Jan 16, 2014
P2, N=22, Terminated,  Sponsor: Eastern Cooperative Oncology Group
After stage one, the study was terminated due to excess toxicity. N=42 --> 22

|||||||||| Trial completion, HEOR: Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia (clinicaltrials.gov) - Jan 16, 2014
P=N/A, N=1264, Completed, Sponsor: Amgen
N=42 --> 22 Active, not recruiting --> Completed

||||||||||  prednisone / Generic mfg.
New P4 trial:  Reduction in Symptomatic Esophageal Stricture Formation (clinicaltrials.gov) -  Jan 15, 2014
P4, N=126, Not yet recruiting,  Sponsor: Florida Hospital

||||||||||  ONO-8539 / Ono Pharma
Enrollment closed:  A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers (clinicaltrials.gov) -  Jan 15, 2014
P1, N=20, Active, not recruiting,  Sponsor: Ono Pharmaceutical Co. Ltd
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment open: Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer (clinicaltrials.gov) - Jan 14, 2014
P3, N=280, Recruiting, Sponsor: Yin Li
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Trial completion: Esophageal High Resolution Manometry and Dysphagia (clinicaltrials.gov) - Jan 13, 2014
P=N/A, N=247, Completed, Sponsor: Hospices Civils de Lyon
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  TheraCIM (nimotuzumab) / Daiichi Sankyo, Oncoscience, Biocon
New P2 trial, Metastases:  Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma (clinicaltrials.gov) -  Jan 12, 2014
P2, N=40, Not yet recruiting,  Sponsor: Zhejiang University

||||||||||  5-fluorouracil / Generic mfg., albumin-bound paclitaxel / Generic mfg.
New P2 trial, Surgery, Metastases:  Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus (clinicaltrials.gov) -  Jan 8, 2014
P2, N=40, Not yet recruiting,  Sponsor: Zhejiang University

||||||||||  colesevelam (IW-3718) / Ironwood Pharma
New P2 trial:  Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors (clinicaltrials.gov) -  Jan 7, 2014
P2, N=90, Recruiting,  Sponsor: Ironwood Pharmaceuticals, Inc.

|||||||||| Enrollment closed: Racial Disparity in Barrett's Esophagus (clinicaltrials.gov) - Jan 7, 2014
P=N/A, N=400, Active, not recruiting, Sponsor: University of North Carolina, Chapel Hill
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment closed: Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus? (clinicaltrials.gov) - Jan 7, 2014
P=N/A, N=70, Active, not recruiting, Sponsor: University of North Carolina, Chapel Hill
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Trial completion: Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients (clinicaltrials.gov) - Jan 7, 2014
P3, N=45, Completed, Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Recruiting --> Active, not recruiting Recruiting --> Completed

|||||||||| Enrollment change: CryoSpray Ablation (TM) GI Patient Registry (clinicaltrials.gov) - Jan 7, 2014
P=N/A, N=199, Completed, Sponsor: CSA Medical, Inc.
Recruiting --> Completed N=500 --> 199

|||||||||| Enrollment open: Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer (clinicaltrials.gov) - Jan 7, 2014
P=N/A, N=1000, Recruiting, Sponsor: Xijing Hospital of Digestive Diseases
N=500 --> 199 Not yet recruiting --> Recruiting

|||||||||| Trial completion: CryoSpray Ablation (TM) GI Patient Registry (clinicaltrials.gov) - Jan 7, 2014
P=N/A, N=199, Completed, Sponsor: CSA Medical, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  lansoprazole / Generic mfg.
Trial termination:  Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD (clinicaltrials.gov) -  Jan 5, 2014
P=N/A, N=24, Terminated,  Sponsor: University of Rochester
Active, not recruiting --> Completed Recruiting --> Terminated; Expected recruitment numbers have not been achieved.

||||||||||  lansoprazole / Generic mfg.
Enrollment change:  Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD (clinicaltrials.gov) -  Jan 5, 2014
P=N/A, N=24, Terminated,  Sponsor: University of Rochester
Recruiting --> Terminated; Expected recruitment numbers have not been achieved. N=40 --> 24

||||||||||  K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P2 trial:  Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis (clinicaltrials.gov) -  Jan 5, 2014
P2, N=200, Recruiting,  Sponsor: CJ Cheiljedang Corporation

||||||||||  TheraCIM (nimotuzumab) / Daiichi Sankyo, Oncoscience, Biocon
Enrollment open, Metastases:  Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma (clinicaltrials.gov) -  Jan 4, 2014
P2, N=20, Recruiting,  Sponsor: Zhejiang University
N=40 --> 24 Not yet recruiting --> Recruiting

||||||||||  TheraCIM (nimotuzumab) / Daiichi Sankyo, Oncoscience, Biocon
Trial completion, Metastases:  A Study of Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer (clinicaltrials.gov) -  Jan 2, 2014
P2/3, N=104, Completed,  Sponsor: Eurofarma Laboratorios S.A.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed



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