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Rectal Cancer clinical trials

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NCT ID: NCT02178644 Completed - Rectal Cancer Clinical Trials

Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer

Start date: July 2014
Phase: Phase 1
Study type: Interventional

This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.

NCT ID: NCT02177084 Not yet recruiting - Rectal Cancer Clinical Trials

Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

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

The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B). The secondary aims are the evaluation of the following parameters: - Effect of PTNS on manometric parameters - Effect of PTNS on quality of life - Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation - Safety of PTNS

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: NCT02153853 Enrolling by invitation - Obesity Clinical Trials

Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?

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

Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications. The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer. The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality. The investigators hypothesise that increased BMI does not increase the risk of conversion.

NCT ID: NCT02140723 Recruiting - Rectal Cancer Clinical Trials

p53 and Response to Preoperative Radiotherapy for T2 and T3

PART1
Start date: August 2011
Phase:
Study type: Observational

Background: Meta-analyses of large randomized trials proved the superiority of preoperative short course radiation and surgery, as compared with surgery alone. Short course radiation results in a 50% reduction in terms of local relapse in stage II and III rectal cancer patients. Patients with complete pathological remission additionally show a significant survival benefit. Complete pathological remission (pCR) occurs in 8% after preoperative radiation and in >16% if the interval between radiation and surgery is at least 8 weeks. It is generally accepted that mutations in the TP53 gene represent a crucial defect in the apoptosis pathway. Radiation therapy is suggested to act via induction of apoptosis in irradiated cells. Therefore, it is expected that a defect in the TP53 gene has an effect on the success of radiation therapy. Currently available imaging tools are hardly able to diagnose response to radiation therapy correctly, as this does not essentially correlate with tumor size. Method: Aim of this prospective observation study is to strengthen the hypothesis that the TP53 genotype is a promising marker to predict response to radiation therapy in rectal cancer patients. Consequently, the expected results will justify prospective, randomized intervention trials to obtain level of evidence I for the p53 marker hypothesis. Trial endpoint is downstaging and pCR rate. Tumor stage and pathological remission will be evaluated by MRT and pathohistology and correlated to the TP53 genotype of the diagnostic biopsy. Additionally, we will investigate the applicability of novel imaging modalities in magnet resonance tomography to monitor response to radiotherapy. The objective of this study is - to evaluate the effect of a genetic tumor marker (TP53 genotype) on the response to preoperative short course radiation (in terms of downstaging and pCR rate) - to evaluate the applicability of novel magnet resonance tomography imaging modalities to monitor response to preoperative short time radiation. Conclusion: The prospective evaluation of the potential predictive marker TP53 may bring us one-step closer to an individualized therapy regimen, which allows the restriction of preoperative radiation in rectal cancer to those patients who will benefit.

NCT ID: NCT02129049 Completed - Breast Cancer Clinical Trials

Telephone-Based Educational Intervention in Improving Communication Between Patients With Stage 0-III Cancer and Their Children

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

This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.

NCT ID: NCT02127645 Completed - RECTAL CANCER Clinical Trials

Neoadjuvant Radiotherapy Followed by Transanal Endoscopic Microsurgery for T1-T2 Extraperitoneal Rectal Cancer

NERATEM
Start date: June 2011
Phase: Phase 3
Study type: Interventional

Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant already for T1 invasive cancers with submucosa infiltration >1 mm it is our intention to investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined treatment in a case series comparing results of this pilot study to an historical series of patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no neoadjuvant therapy. If equally effective, TEM offers a further reduction in invasiveness of treatment, which should correspond to a lower morbidity, mortality and a better quality of life.

NCT ID: NCT02113384 Active, not recruiting - Rectal Cancer Clinical Trials

Locally Advanced Rectal Cancer - Exfoliated Peritoneal Tumor Cells

LARC-EX
Start date: September 2012
Phase:
Study type: Observational [Patient Registry]

During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the time of surgery might therefore be of value for prediction of disease recurrence with subsequent prognostic implications for these patients. In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.

NCT ID: NCT02112747 Completed - Rectal Cancer Clinical Trials

Adherence to Colon Cancer Screening (ACCS)

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

This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.