View clinical trials related to Rectal Neoplasms.
Filter by:The objective of the TransValid-KFO179/GRCSG-Trial-A is the validation of potential biomarkers. These are predictive (Prediction of probability of response to a certain therapy) / prognostic (predicting long-term outcome) microarray-based gene expression signatures and immunohistochemically evaluated biomarkers. The evaluation was done within the KFO179 (www.kfo179.de) - the validation is implemented in this trial. Therefore tumor material of patients undergoing standard radiochemotherapy will be analyzed from pretreatment biopsies an residual tissue from the resection specimen after surgery. This validation and the biomaterial asservation will be incorporated into clinical routine in all participating centers as a model for the treatment of solid tumors. The obtained biomarkers with a predictive and prognostic power will be used to develop an algorithm to predict patients at high risk of local and distant cancer recurrence.
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery. SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.
The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.
The purpose of this study is to see how effective and safe LY2157299, in combination with chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this study, research will be done on tumor samples to see if it is possible to predict if patients will respond to treatment, and blood samples to look at the immune system response to study treatment. About 50 people will take part in this study. The study treatment will be given over an 8 week period and the investigators will continue to collect your health information for up to 5 years, as part of this study
The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.
Early cancers of the rectum can be removed safely through the anus without subjecting patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence, hospital stay and avoiding a stoma that may be associated with pelvic surgery. Currently few of the patients eligible for TEMS are offered it for a variety of reasons that include uncertainties about the risk of leaving residual tumour and the increased risk of subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no role for imaging in assessing the malignant polyp. Conversely whilst retrospectively reviewing their MRI databank the investigators have found evidence that MRI can accurately judge the depth of these early tumours and thereby potentially identify patients for local excision. The investigators hope to prospectively test their hypothesis that an MRI scan can accurately gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring between 20mm and 50mm in size. The investigators will identify eligible patients awaiting surgery / polypectomy and if they consent to this pilot study participants will undergo an MRI to assess their tumour which assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established by reference to gold standard histopathology. Should MRI prove sensitive and specific then the investigators hope to change national guidelines to mandate MRI to standardise assessment and thereby increase the appropriate use of TEMS in the UK.
Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes. The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.
The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%). Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma. Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.