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Rectal Cancer clinical trials

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NCT ID: NCT02163785 Terminated - Rectal Cancer Clinical Trials

Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position

APPRO
Start date: June 2014
Phase: N/A
Study type: Interventional

Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer. Primary objective: - Pathological circumferential resection margin Secondary objectives: - 5 year oncological outcomes - Morbimortality rates - Surgical specimen quality - Perineal hernia incidence

NCT ID: NCT02163187 Terminated - Rectal Cancer Clinical Trials

Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

Start date: June 10, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.

NCT ID: NCT02057991 Terminated - Depression Clinical Trials

Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers

Start date: January 7, 2014
Phase: N/A
Study type: Interventional

This randomized pilot trial studies mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with colorectal cancer and their caregivers.

NCT ID: NCT02052921 Terminated - Rectal Cancer Clinical Trials

Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy

Start date: November 2011
Phase: N/A
Study type: Interventional

With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. So far, this approach remains discussed in the literature, and there are still many uncertainties that patients with clinical complete response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of radical surgical treatment. It is a still investigational approach and actually gained space even for patients with very high or who refuse surgery after all clarifications surgical risk. Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who underwent surgical rectal resection. This will be a prospective, randomized, open label phase II of surgical resection versus conservative treatment (observation) in patients with mid and distal rectal cancer who achieved complete after neoadjuvant chemoradiotherapy combined with clinical response. The main objective of this study is to assess whether conservative approach is similar to rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum in patients with complete clinical response after neoadjuvant therapy combined chemoradiotherapy. Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors. Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The period for randomization of patients will be 12 weeks after the last dose of radiotherapy / chemotherapy, so that we can properly assess the antitumor response as described above. After randomization, patients in the surgical group will undergo resection of the rectum with complete excision of mesorectal within 2 weeks after randomization.

NCT ID: NCT02010567 Terminated - Rectal Cancer Clinical Trials

Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer

Start date: December 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This trial will enroll patients with locally advanced rectal cancer (resectable and non-resectable).The phase Ib dose escalation portion of trial is designed to determine the maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP) formulation of camptothecin. These results will determine the recommended phase II dose (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation therapy prior to surgery.

NCT ID: NCT01995396 Terminated - Rectal Cancer Clinical Trials

Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

HAPIrect
Start date: February 2014
Phase: N/A
Study type: Interventional

In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable. In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

NCT ID: NCT01887509 Terminated - Rectal Cancer Clinical Trials

Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology

TRaMA
Start date: November 7, 2013
Phase: N/A
Study type: Interventional

This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) will be compared to histopathology analysis. This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam. The proposed study is a feasibility study, first in the indication of rectal cancer.

NCT ID: NCT01717014 Terminated - Rectal Cancer Clinical Trials

Radial Reload Open LAR Case Series

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

The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.

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: NCT01544452 Terminated - Rectal Cancer Clinical Trials

Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer

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

Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic evaluation before surgery. MR colonography have been shown to have high sensitivity and specificity for larger polyps and cancer and MRI of the liver have been shown to have similar or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of two or three different methods of evaluation. The investigators hypothesis is that the total MR evaluation is equal or superior to the existing preoperative evaluation regarding the diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the total diagnostic evaluation.