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Rectal Neoplasms clinical trials

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NCT ID: NCT03567850 Completed - Colo-rectal Cancer Clinical Trials

Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC

Start date: October 19, 2018
Phase: N/A
Study type: Interventional

The aim of this 2-year study will assess the acceptability and feasibility of offering Problem Solving Skills Therapy (PSST) to cancer survivors and their caregivers focusing on the highest risk patients with distress.

NCT ID: NCT03565029 Completed - Colo-rectal Cancer Clinical Trials

Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer

NO-CUT
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in patients with operable rectal cancer, without increasing the risk of distant relapse. The trial also has a translational component aimed at establishing whether selected genomic, epigenetic, and transcriptomic markers are predictive of tumor and patient outcome.

NCT ID: NCT03541304 Completed - Rectal Cancer Clinical Trials

High Dose Radiotherapy for the Treatment of Rectal Cancer

Start date: January 1, 2017
Phase:
Study type: Observational

While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician. After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded. Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.

NCT ID: NCT03524716 Completed - Colorectal Cancer Clinical Trials

Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II

SmartPaceII
Start date: March 6, 2018
Phase: N/A
Study type: Interventional

There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.

NCT ID: NCT03491540 Completed - Clinical trials for Rectal Cancer Surgery

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

PREPACOL2
Start date: September 3, 2018
Phase: Phase 3
Study type: Interventional

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone

NCT ID: NCT03463616 Completed - Rectal Cancer Clinical Trials

MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?

Start date: March 15, 2018
Phase:
Study type: Observational

Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio-frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens. These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery. In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative. MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels. The aim of this study is to examine the possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.

NCT ID: NCT03443661 Completed - Clinical trials for Locally Advanced Rectal Cancer

Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Start date: February 6, 2016
Phase: Phase 2
Study type: Interventional

This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

NCT ID: NCT03428529 Completed - Clinical trials for Rectal Neoplasm Malignant

Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

INCAGI004
Start date: January 12, 2011
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.

NCT ID: NCT03420443 Completed - Rectal Cancer Clinical Trials

Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

FIPIREX
Start date: November 2008
Phase: N/A
Study type: Interventional

The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.

NCT ID: NCT03392584 Completed - Infection Clinical Trials

Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters

Start date: October 1, 2016
Phase:
Study type: Observational

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.