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Gastrointestinal Neoplasms clinical trials

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NCT ID: NCT02550119 Terminated - Nausea and Vomiting Clinical Trials

Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

Start date: April 19, 2006
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.

NCT ID: NCT02417753 Terminated - Ovarian Cancer Clinical Trials

AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites

Start date: April 3, 2015
Phase: Phase 2
Study type: Interventional

Background: - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer. Objective: - To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer. Eligibility: - Adults age 18 and older with a malignancy of the GI tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen. Design: - Participants will be screened with: - Medical history, physical exam, and blood tests. - Echocardiogram: sound waves make images of the heart. - Electrocardiogram: measures electrical activity of the heart. - Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid. - They may have a tumor biopsy. - Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days. - Each cycle, participants will: - Have a physical exam. - Have blood tests weekly. - Be asked about how they feel and any medicines they are taking. - After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor. - Participants will have paracentesis 2 more times during the study. They will have another echocardiogram. - At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.

NCT ID: NCT02268825 Terminated - Advanced GI Cancer Clinical Trials

Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers

MK-3475 GI
Start date: January 23, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival and overall survival. The safety expansion cohort will assess the effect of the addition of celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.

NCT ID: NCT02080702 Terminated - Clinical trials for Gastrointestinal Neoplasms

An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract

PROMEGAT
Start date: August 2014
Phase:
Study type: Observational

The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter. Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints. The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.

NCT ID: NCT02066363 Terminated - Quality of Life Clinical Trials

Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is associated with a poor prognosis and is an important predictor of mortality. Supplementation with home parenteral nutrition in aphagic and terminal patients has shown improved quality of life, energy balance, body composition and prolonged survival. Aim: The aim of this study is primarily to study the effects of supplementation with parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean body-mass and body composition. Patients found to be at nutritional risk will be included in the study and will be randomized to either best supportive nutritional care or best supportive nutritional care and supplemental Parenteral Nutrition. Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced GI cancers at nutritional risk, performance status 0-2 and with an expected survival of a minimum of 3 months. A total of 100 patients are planned to be enrolled and randomized to either best supportive nutritional care or best supportive nutritional care and supplemental parenteral Nutrition. Primary endpoint is improvement of lean body mass, and by that improvement of quality of life, performance status and cancer treatment tolerance. Discussion: The planned study will provide important information about the effect of parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative treatment strategies are set up to improve quality of life as well as prolongation of life. Parenteral nutrition in this patient group may indeed contribute to both these aspects of palliation.

NCT ID: NCT02008539 Terminated - Clinical trials for Advanced Gastrointestinal Cancer

Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

TREAT-ME 1
Start date: October 2013
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and tolerability of MSC_apceth_101.

NCT ID: NCT02005614 Terminated - Breast Cancer Clinical Trials

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.

NCT ID: NCT01939210 Terminated - Depression Clinical Trials

Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy

Start date: February 2010
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies the effects of meditation-based breathing training on patients' control of their breathing patterns and breathing-related movement, as well as on their psychological distress and treatment experience during radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress by improving breathing patterns in patients with abdominal or lung cancer undergoing radiation therapy.

NCT ID: NCT01853241 Terminated - Clinical trials for Inflammatory Bowel Disease

Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy

Start date: May 2010
Phase: N/A
Study type: Observational

The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins. The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.

NCT ID: NCT01790035 Terminated - Clinical trials for Gastrointestinal Neoplasms

Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer

LGG
Start date: August 19, 2014
Phase: Phase 1
Study type: Interventional

Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety lead-in.