View clinical trials related to Rectal Cancer.
Filter by:Anastomotic failure (AF), including anastomotic leakage (AL), increases morbidity and mortality after colorectal cancer (CRC) resection. An inadequate perfusion of the anastomosis or technical stapling defects may contribute to AF. Several studies evaluated the singular use of intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis. So far, a combined use of these methodologies, although acknowledged has not yet been tested as an indicator of postoperative AF or of intra-operative anastomotic repair in a prospective setting. This study aims to implement the intraoperative anastomotic assessment in a prospective series of patients undergoing rectal resection plus primary anastomosis for rectal cancer with or without ostomy, using a semi-quantitative check of 4 items (4-check). The procedure will include NIR-ICG-induced FA (to assess perfusion), air leak test and evaluation of the anastomotic donuts (to assess for the presence of technical defects). Included patients will be those scheduled for elective rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy. Primary outcomes will be the overall incidence of intra-operative anastomotic repair and the rate of post-operative AF. Secondary outcomes will be the overall incidence of adverse events and serious complications, the estimation of costs and resources, the operative time, hospitalization and post-operative measurement of inflammatory markers.
PRIME-RT is an open label, multi-centre phase II randomised trial with 1:1 allocation between arm A and arm B. The principal research question is whether the addition of durvalumab to FOLFOX chemotherapy and radiation treatment (either SCRT or LCRT) in the neoadjuvant setting for patients with locally advanced rectal cancer (LARC) improves rates of complete response. The working hypothesis is that the use of radiation and cytotoxic chemotherapy may prime the tumour immune microenvironment for treatment with immune checkpoint blockade. The main trial will commence after completion of a safety run-in which will enrol at least three patients per arm to test the safety and tolerability of the treatment combinations in each.
The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.
Background Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations however there have been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits cannot be measured accurately. The primary objective of this pilot study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, recruitment feasibility and protocol refinement. Method This pilot study will be a prospective, observational, case-matched, two -cohort, multicentre designed to investigate the oncological and clinical outcomes of patients with mid-to-low, non-metastatic rectal cancer undergoing low anterior resection (LAR) using robot-assisted surgery ( RLAR), or transanal total mesorectal excision (TaTME). The inclusion criteria consist of experienced surgeons defined as 60 prior procedures with RLAR or TaTME to meet the enrolment criteria for the RLAR and TaTME arm, respectively. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Secondary and exploratory endpoints will include length of hospital stay, intraoperative time, intraoperative blood loss, harvested lymph nodes, distal resection margin, incompleteness of mesorectum, CRM involvement, unplanned conversion rates, 30-days postoperative complications and overall recurrence rate. The Quality of life assessment questionnaires will be performed preoperatively, 6 months and 12 months after reversal of ileostomy. Propensity score matching will be used to minimize bias from the nonrandomized treatment assignment. The RLAR and TaTME cohorts will be matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or TaTME occurrence on logistic regression analysis. Ethics and Dissemination The medical ethical committees of all the participating countries will be involved in approving the study protocol. Results of the primary and secondary end points will be submitted for publication in peer-reviewed journals.
The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment. Objectives 1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT. 2. To preliminary assess the potential value of PET/MR in predicting pMR to nT. 3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.
The TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection. The study aims to develop an anastomotic leakage severity score and to evaluate the efficacy of different treatments of anastomotic leakage.
This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.
A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision，transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer