Neoplasms

Digestive System Diseases

All Conditions

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Lipid Regulating Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Herbal and Botanical

Simvastatin

Calcium

Calcium, Dietary

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Cola

40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op

40mg orally, given 3-7 days pre-op and continued till 14 days post-op

Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)

Placebo

Andrew G Hill, MBChB MD FRACS

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery.

Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.

Simvastatin in Colorectal Surgery

Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery

Complications pre-defined and graded by the Clavien-Dindo classification

Counties Manukau Health

Waitemata District Health Board

Auckland District Health Board

University of Auckland, New Zealand

Professor Andrew Hill

Rare Diseases

Rectal Neoplasms

Stomach Neoplasms

Stomach Diseases

Colorectal Neoplasms

Rectal Diseases

Stomach Cancer

Glycerol

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

endoscopic sub-mucosal dissection

PINSET CHRISTIAN, CEO

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).

Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

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

TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months

Hôpital Edouard Herriot

Thieery Ponchon

Carcinoma

Colonic Diseases

Antineoplastic Agents

Micronutrients

Oxaliplatin

Bevacizumab

Fluorouracil

Irinotecan

Tetrahydrofolates

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Modufolin in combination with 5-Fluorouracil only.

Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime

Modufolin in combination with 5-Fluorouracil and Irinotecan.

Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime

Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab

Modufolin in combination with 5-Fluorouracil and Irinotecan

IV injection every second week for 8 weeks.

Modufolin (arfolitixorin)

IV infusion every second week for 8 weeks.

Göran Carlsson, MD

The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab.

Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.

The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan.

When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan.

Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Simvastatin in Colorectal Surgery	NCT00994903	Intestinal Neop... Perioperative C...	Simvastatin Placebo	18 Years - 90 Years	University of Auckland, New Zealand
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System	NCT01910974	Stomach Neoplas... Intestinal Neop... Rectal Neoplasm	endoscopic sub-...	18 Years - 90 Years	Hôpital Edouard Herriot
Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer	NCT02244632	Colorectal Neop...	Modufolin (arfo... Fluorouracil Oxaliplatin Irinotecan Bevacizumab	18 Years -	Isofol Medical AB
Simvastatin in Colorectal Surgery	NCT00994903	Intestinal Neop... Perioperative C...	Simvastatin Placebo	18 Years - 90 Years	University of Auckland, New Zealand

Spots Global Cancer Trial Database for intestinal neoplasm