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Intestinal Neoplasms clinical trials

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NCT ID: NCT02608203 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

[68 Ga]-DOTANOC PET/CT in GEP-NETs

GEP-NOC
Start date: May 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs. During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs. In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa. Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar. [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation. It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients. The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS). 110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).

NCT ID: NCT02585362 Completed - Breast Cancer Clinical Trials

Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Start date: March 2016
Phase: N/A
Study type: Interventional

This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.

NCT ID: NCT02489422 Completed - Depression Clinical Trials

Programs To Support You During Chemotherapy

PRO-YOU
Start date: August 2016
Phase: N/A
Study type: Interventional

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

NCT ID: NCT02231762 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

SONNET
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).

NCT ID: NCT02200055 Completed - Pancreatic Cancer Clinical Trials

Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need

Start date: May 2012
Phase: N/A
Study type: Interventional

Being able to accurately monitor patient bodily fluid levels during and after surgery is very important, as there are a number of complications that can arise if a patient's fluid levels become unbalanced, such as swelling within or pressure on various bodily organ systems. There are several different ways that physicians can monitor a patient's fluid balance during and after surgery, such as measuring the amount of urine output or the use of central venous catheters which measure the pressure in the veins entering the heart. Most of these techniques are invasive since they require tubes to be inserted into the body. A potential alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA). Bioimpedance assessments work by using small electrical currents that can accurately predict both the water surrounding the outside of cells in the body, as well as the total amount of water in the entire body. Electrical bioimpedance assessments have been used to estimate patient swelling following surgery (edema), to measure the volume of blood the heart is pumping out, as well as to calculate body fat percentages. The goal of this study is to relate this technology to fluid shifts within the body that occur as a result of surgery, in particular, major intra-abdominal surgeries. By using bioimpedance during and after surgery, the investigators will compare the data collected with that calculated by using traditional measures of body fluid status, such as urine output and intraoperative blood loss. During the study, the bioimpedance monitors will not replace the standard bodily fluid monitors and will not interfere with their readings. Additionally, the electrical current produced by the bioimpedance monitors is too small for patients to feel and will not interfere with medical devices such as pacemakers.

NCT ID: NCT01996306 Completed - Clinical trials for Colorectal Neoplasms

A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

AXEPT
Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

NCT ID: NCT01910974 Completed - Stomach Neoplasm Clinical Trials

Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

Start date: July 2012
Phase: N/A
Study type: Interventional

safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

NCT ID: NCT01747096 Completed - Clinical trials for Patients With Gastroenteropancreatic Neuroendocrine Tumors

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

68-DOTANOC-GEP
Start date: November 2012
Phase: N/A
Study type: Interventional

Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.

NCT ID: NCT01563991 Completed - Clinical trials for Benign Neoplasm of Intestinal Tract

Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

Start date: February 2007
Phase: N/A
Study type: Interventional

Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

NCT ID: NCT01263353 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System

Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

COOPERATE-1
Start date: November 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).