View clinical trials related to Rectal Neoplasms.
Filter by:The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography. The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.
This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
This phase I trial studies the side effects and best dose of ropidoxuridine and how well it works when added to the usual chemotherapy treatment (capecitabine) during radiation therapy for the treatment of patients with stage II-III rectal cancer. Ropidoxuridine may help radiation therapy work better by making cancer cells more sensitive to the radiation therapy. Chemotherapy drugs, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out whether ropidoxuridine in addition to capecitabine and radiation therapy works better in treating patients with rectal cancer.
BACKGROUND and RATIONALE Colorectal cancer, with 49,000 new diagnoses expected in 2019 (27,000 in men and 22,000 in women) represents, in Italy, the third neoplasm in men (14%) and the second in women (12%). Increasing attention has been recently paid to the outcomes of surgical treatment, in terms of patient's anorectal function and quality of life (QoL). Currently, the majority of patients affected by rectal carcinoma undergo a sphincter-sparing surgery, that is, a low anterior rectal resection (LAR). It is known that about 50% - 90% of patients undergoing LAR will develop at least some degree of bowel dysfunction: for this reason, the definition of "anterior low rectal resection syndrome" (LARS) has been coined to describe this complex functional condition; the LARS usually includes incontinence to gas and/or liquid or solid stools, constipation, urgency, fragmentation and frequent bowel movements; a worsening of QoL has been also observed. Due to the importance and high prevalence of this condition, but in the absence of a reliable tool for assessing its severity, the so-called "LARS score" has been introduced. The score has already been validated in several languages, even if this important tool has not been validated in Italian language. AIMS of the STUDY The primary aim of this study will be the validation in Italian language of the LARS score in a population of Italian patients with a previous history of rectal cancer and treated by anterior rectal resection surgery. Moreover, the convergent and discriminatory validity, and the reliability of the score will be also assessed. STUDY DESIGN The study will be a prospective observational study on patients affected by rectal cancer and treated by anterior rectal resection surgery with total or partial excision of the mesorectum (TME, total mesorectal excision, or PME, partial mesorectal excision) in the period January 2000 - April 2018. Any Unit of the Fondazione Policlinico Universitario "Agostino Gemelli" - IRCCS of Rome that deals with rectal cancer surgery could join the study. METHODS The validated English version of the LARS questionnaire will be translated into Italian. The translation will be performed by two independent professional translators. Based on previous validation studies conducted in other Countries, it has been calculated that the sample size will be 200 patients. Patients will be assessed by administration of the LARS score questionnaire, of a single question on QoL, and of the EORTC-QLQ-C30 questionnaire. Each Unit could choose to assess the patients in the preferred way (clinical follow-up visit, e-mail, ordinary mail); however, the method of administration of the questionnaire must be specified in the final communication of data to the coordinating Group. Each Unit joining the Study will be provided with an Excel data collection sheet which must then be completed. A descriptive analysis of the data will be conducted, and the convergent validity, that is the concordance between the LARS score and the QoL, will be investigated. In addition, discriminatory validity, i.e. the ability of the LARS score to distinguish between subgroups of patients, which usually differ in the LARS score, will be assessed. Finally, the test-retest reliability of the LARS score will be examined, so all patients will receive a second LARS questionnaire 1-2 weeks after completing the first and the results of the two tests will be compared.
Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait strategy (W&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by total neoadjuvant treatment. Meanwhile we will look into the role of ctDNA in the prediction of regrowth and metastasis in the wait and wait process. Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor, mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR were recommended for 'watch & wait' approach or local excision (LE). The OPR and sphincter preservation rate (SPR) at 2 years will be analyzed. As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research enrolled 3 other colorectal center in Beijing.
The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined. We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.
Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigator's prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas. Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires. Secondary endpoints will be: - to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+); - the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height; - the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection.
Background: laparoscopic resection (LAR) is a safe approach and widely used for rectal cancer after neoadjuvant chemo-radiotherapy, but short term and oncological outcome for converted cases to open surgery (cLAR), may be questioned in an obese patient. Objective: validating the short-term and oncological outcomes after laparoscopic resection and after conversion to open surgery for upper rectal cancer in obese patients. Patients and methods: A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.
The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. We will evaluate whether Dendrobium Huoshanense Granules can enhance the immune function and alleviate symptoms caused by the tumor and CRT .
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.