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Rectal Cancer clinical trials

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NCT ID: NCT01643070 Active, not recruiting - Rectal Cancer Clinical Trials

Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases

Start date: January 2010
Phase: Phase 2
Study type: Interventional

To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or marginally resectable rectal cancer with resectable synchronous liver metastases.

NCT ID: NCT01609504 Completed - Rectal Cancer Clinical Trials

ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER

ELRRvsLTME
Start date: April 1997
Phase: Phase 3
Study type: Interventional

The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.

NCT ID: NCT01606098 Completed - Rectal Cancer Clinical Trials

The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer

CAIRO4
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The clinical benefit of resection of the primary tumour in patients with synchronous unresectable metastases is not known. In the literature studies usually describe retrospective selected patients with synchronous metastases treated with or without resection of the primary tumour. All these studies are biased in patient selection and there are no prospective randomized studies on this topic. In patients with few or absent symptoms of the primary tumour, arguments both in favour and against initial resection have been presented, and therefore a randomized trial is warranted. Although recent publications suggest that resection of the primary tumour in synchronous metastasized colon cancer patients might not be necessary, this appears to be based on feasibility and not on clinical outcome. Several studies comparing large groups of patients with or without resection of the primary tumour suggest an improved survival when the primary tumour is resected. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour during chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the primary tumour prior to study entry, had an improved survival compared to patients without a resection of the primary tumour. However, these patients were selected after the primary tumour was resected and therefore these results are not corrected for surgical morbidity and mortality. The investigators here propose a randomized trial in order to demonstrate that resection of the primary tumour does improve overall survival.

NCT ID: NCT01605318 Terminated - Rectal Cancer Clinical Trials

Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

Start date: February 12, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.

NCT ID: NCT01589471 Completed - Rectal Cancer Clinical Trials

The Value of Botox-A for Management of Low Anterior Resection Syndrome

Start date: May 2012
Phase: Phase 2
Study type: Interventional

Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases. One possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. These include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery. Current available treatments are often ineffective, highlighting the need for more successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. It is currently used for the treatment of various smooth muscle spastic diseases. The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical treatment alternative for LARS. The goal of this study is to document the effects of intra-rectal BTX-A injections on sphincter function and quality of life of patients with LARS.

NCT ID: NCT01586117 Recruiting - Rectal Cancer Clinical Trials

A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

NCT ID: NCT01585727 Completed - Rectal Cancer Clinical Trials

Intraoperative Monitoring of the Pelvic Autonomic Nerves

NEUROS
Start date: June 2012
Phase: N/A
Study type: Interventional

One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME). The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.

NCT ID: NCT01582750 Unknown status - Rectal Cancer Clinical Trials

Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy

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

The purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.

NCT ID: NCT01579721 Completed - Rectal Cancer Clinical Trials

Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Start date: September 2011
Phase: Phase 4
Study type: Interventional

Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery. Design: randomized, prospective clinical study Patients: 40 patients

NCT ID: NCT01579591 Recruiting - Rectal Cancer Clinical Trials

VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.