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Gastrointestinal Neoplasms clinical trials

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NCT ID: NCT02894775 Completed - Digestive Cancer Clinical Trials

Factors Influencing Inclusion in Digestive Cancer Clinical Trials

INDICT
Start date: January 2013
Phase: N/A
Study type: Observational

Since the early 1990s, evidence-based medicine has played an increasingly important role in decision-making for the treatment of patients with cancer. The highest level of evidence is attributed to the results of randomized comparative studies, and the public health authorities require proof from randomized therapeutic trials before authorizing the use of new treatments. Patients included in therapeutic trials benefit either from the best current treatment (control group) or from a treatment supposed to present a better or similar efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize the fight against cancer, French public health policies have led to the progressive implementation of successive nationwide "Cancer Plans" since 2003. One of the objectives is to increase the proportion of patients included in clinical research trials. Thus, the fraction enrolled in France has progressively increased but remained low at around 8% in 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a context of socio-economic inequalities that concern resources, residence and access to services, identifying factors that determine inclusion in trials will in turn highlight the reasons for non-inclusion. The aim of this study was to determine, at a population level, the influence of demographic characteristics and socio-economic status of patients with digestive cancer on inclusion in a clinical trial. Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.

NCT ID: NCT02853474 Completed - Gastric Cancer Clinical Trials

Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy

EPIC-1511
Start date: October 2016
Phase: Phase 3
Study type: Interventional

This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).

NCT ID: NCT02842047 Completed - Clinical trials for Stage IV Gastrointestinal Cancer

The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. The purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. One group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. Investigators will randomly assign participants to each group.

NCT ID: NCT02797197 Completed - Sarcopenia Clinical Trials

Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy

FIGHTDIGO
Start date: May 18, 2016
Phase: N/A
Study type: Interventional

Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). There is a high prevalence in elderly and in patients with cancer. Several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities. Diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip test with a "Jamar®" hydraulic hand dynamometer. CT scan is more invasive and less easy to reach than handgrip test. This test is used to be performing in elderly but not in cancer patients having chemotherapy. Present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.

NCT ID: NCT02785887 Completed - Breast Cancer Clinical Trials

Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients

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

This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).

NCT ID: NCT02785783 Completed - Clinical trials for Gastrointestinal Disease

Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

Erings™
Start date: May 13, 2016
Phase: N/A
Study type: Interventional

This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.

NCT ID: NCT02784652 Completed - Clinical trials for Gastrointestinal Cancer

Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors

Start date: June 2014
Phase: Phase 2
Study type: Interventional

Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis. The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone. Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.

NCT ID: NCT02781532 Completed - Clinical trials for Digestive System Neoplasms

Evaluation of Predictive Visual Analog Scale (VAS) for Determining the Ingesta of Patients Carrying a Digestive Cancer

Start date: April 2014
Phase: N/A
Study type: Observational

The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).

NCT ID: NCT02760199 Completed - Clinical trials for Advanced Gastrointestinal Cancer

89Zr-AMG211 PET Imaging Study

Start date: August 2016
Phase: Phase 1
Study type: Interventional

AMG 211 is a bispecific single-chain antibody construct of the bispecific T-cell engager (BiTE®) class that targets human carcinoembryonic antigen (CEA, CD66e) on (tumor) cells and cluster of differentiation 3 (CD3) positive T-cells. AMG 211 is a potentially new targeted drug in the treatment of relapsed/refractory gastrointestinal adenocarcinoma, since those are CEA expressing tumors. A well-known challenge in current drug development using targeted therapies is the high level of heterogeneity of target expression that is present in specific tumor types. Radio-labeling of AMG 211 with the positron emission tomography (PET) radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of AMG 211 distribution in cancer patients. By performing a 89Zr-AMG211 PET scan prior to treatment with AMG 211, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated. By performing a 89Zr-AMG211 PET scan during AMG 211 continuous intravenous (cIV) treatment the investigators will be able to evaluate the impact of prolonged steady state exposure of AMG 211 on tumor and tissue uptake. The 89Zr-AMG211 PET imaging study may help to identify patients more likely to benefit from AMG 211 therapy.

NCT ID: NCT02742935 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Safety and Tolerability of Using SHR-1210 by Advanced Solid Tumor Subjects

Start date: April 27, 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors.