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Esophageal Neoplasms clinical trials

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NCT ID: NCT02722785 Completed - Clinical trials for Gastro-esophageal Cancer

PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction

PRESET
Start date: April 2016
Phase: N/A
Study type: Interventional

Background: For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function, which are strong predictor of post-surgical complication and survival . A strong rationale exists to explore how to develop supportive interventions aimed at maintaining/improving muscle function (lean body mass and muscle strength) during the pre-surgical phase. This study explores the safety, feasibility and efficacy of structured pre- and post-operative exercise training in patient undergoing surgery for cancer of the gastro-esophageal junction. Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ scheduled for treatment af Rigshospitalet, Copenhagen, Denmark. Methods: In a case-control design, patients will be allocated to either an exercise training intervention group, or a usual-care observational group, based on geographical location. Forty patients will be included in this case-control study and allocated by geographical region as follows; 20 training intervention-cases living in the greater Copenhagen area, and 20 observational control subjects living outside the greater Copenhagen area. All patients will undergo a total of 5 assessments during the perioperative trajectory; twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15 weeks post-surgery, and at 1-year follow-up). Assessments include measures of body composition by DXA scan and bioelectrical impedance analysis: systemic inflammation in fasting blood sample; quality of life by self-report questionnaires; physical function by handgrip strength and sit-to-stand test. As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood samples before, during and after an acute exercise bout exercise in order to explore the acute systemic changes in exercise-regulated biomarkers.

NCT ID: NCT02721563 Completed - Clinical trials for Esophageal Neoplasms

A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC

Start date: February 25, 2016
Phase: Phase 4
Study type: Interventional

This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

NCT ID: NCT02703142 Completed - Clinical trials for Esophageal Neoplasms

Endoscopic Evaluation After Esophagectomy

Start date: October 2015
Phase: N/A
Study type: Observational

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

NCT ID: NCT02699606 Completed - Neoplasm Clinical Trials

A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

Start date: July 8, 2016
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer and cholangiocarcinoma.

NCT ID: NCT02680990 Completed - Clinical trials for Pancreatic Adenocarcinoma

Resilience and Exercise in Advanced Cancer Treatment

REACT
Start date: December 2015
Phase: N/A
Study type: Interventional

This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.

NCT ID: NCT02676791 Completed - Clinical trials for Esophageal Neoplasms

Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

LOCARE
Start date: February 16, 2016
Phase: N/A
Study type: Interventional

The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.

NCT ID: NCT02644408 Completed - Clinical trials for Stage III Esophageal Squamous Cell Carcinoma

Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Start date: October 1, 2014
Phase: Phase 3
Study type: Interventional

Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance put, chemotherapy, improve the quality of life, is widely used in tumor radiation and chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal bleeding, arrhythmia and other serious complications, there is no unified standard. The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical chemoradiation curative effect and side effects, for rational use in the process of radiation and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from China.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment and adverse events.

NCT ID: NCT02642809 Completed - Esophageal Cancer Clinical Trials

Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers

Start date: June 8, 2016
Phase: Phase 1
Study type: Interventional

The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation. Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers in combination with radiation therapy may be a rational treatment strategy for these cancers.

NCT ID: NCT02639065 Completed - Esophageal Cancer Clinical Trials

A Study of Durvalumab (MEDI4736) in Esophageal Cancer

Start date: April 27, 2016
Phase: Phase 2
Study type: Interventional

This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as: - Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed. - Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.

NCT ID: NCT02628951 Completed - Clinical trials for Gastric Adenocarcinoma

Ramucirumab/Paclitaxel as Second-line Treatment in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma With Integrative Genomic Analysis

Start date: May 26, 2016
Phase: Phase 2
Study type: Interventional

Vascular endothelial growth factor is expressed in gastric cancer, and expression has been associated with more aggressive clinical disease. Vascular endothelial growth factor expression has been noted in 51% of gastric cancer specimens in one series (versus no expression in normal epithelium or superficial gastritis). Vascular endothelial growth factor expression in resected gastric cancer is associated with tumor recurrence and shorter survival. Maeda et al. studied 95 gastric cancer patients following resection with curative intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial VEGF expression (p<0.05). Yoshikawa and colleagues observed similar survival differences in resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of resection. Circulating VEGF is significantly higher in gastric cancer patients versus those without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a European cohort undergoing gastric cancer resection; there was no survival beyond 30 months in 24 patients with serum VEGF >533 pg/mL versus a 30-month survival rate >35% for 34 patients with VEGF levels below this threshold (p<0.0001, log-rank test). Recently, Jüttner and colleagues noted reduced survival following R0 resection in gastric cancer patients whose tumors expressed VEGF-C or VEGF-D, with the most robust association between expression and reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D. Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line) is associated with reduced tumor growth. DC101 therapy in this model is associated with significant reductions in tumor vascularity (as measured by CD-31 expression) and increases in endothelial and tumor apoptosis. The results of the REGARD and RAINBOW studies are consistent with the idea that tumor- related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate the ability of ramucirumab to represent an improvement in the care of patients with gastric cancer whose disease has progressed after prior chemotherapy.