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Rectal Neoplasms clinical trials

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NCT ID: NCT04455945 Completed - Quality of Life Clinical Trials

Quality of Life After Rectal Cancer Surgery

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is becoming increasingly important in clinical trials. The investigators aimed to compare long term health related life quality (HRQoL) results of laparoscopic approach with open approach in patients with sphincter preserving resections for rectal cancer at a single-center.

NCT ID: NCT04455737 Completed - Rectal Neoplasms Clinical Trials

Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision

RLF
Start date: October 2013
Phase:
Study type: Observational

Background: An exact lymph node staging is essential in the treatment of rectal cancer. Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME). Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team. Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group). Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection. Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.

NCT ID: NCT04443985 Completed - Rectum Cancer Clinical Trials

A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer

Start date: June 1, 2020
Phase:
Study type: Observational

Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear. Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT.

NCT ID: NCT04443543 Not yet recruiting - Rectal Cancer Clinical Trials

An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer

Start date: June 22, 2020
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04441580 Recruiting - Rectal Neoplasms Clinical Trials

Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting

GENIAL-CO
Start date: May 4, 2020
Phase: N/A
Study type: Interventional

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis. The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).

NCT ID: NCT04423965 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

Start date: May 12, 2020
Phase: Phase 2
Study type: Interventional

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

NCT ID: NCT04418895 Withdrawn - Clinical trials for Rectal Adenocarcinoma

Neoadjuvant Therapy for Localized Rectal Adenocarcinoma

Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This study is a prospective, single-arm, single-center study of investigator's choice of total neoadjuvant therapy (TNT) or neoadjuvant chemoradiation in locally advanced rectal cancer. The standard of care for rectal adenocarcinomas that are triiodothyronine-thyroxine (T3-T4) or node positive has generally been comprised of neoadjuvant chemoradiation, followed by surgical resection and then adjuvant chemotherapy. More recently, TNT, comprised of neoadjuvant chemotherapy and chemoradiation followed by surgical resection, has been increasingly used as a standard therapy approach. While the use of TNT is increasingly common, prospective study of outcomes following TNT has been limited. Moreover, there are not any biomarkers known at this time that impact clinical decision-making or personalization of therapy in the treatment of rectal cancer. In this study, we will collect pre-treatment rectal adenocarcinoma specimens and determine clinical outcome, including pathologic complete response rate, post-treatment pathologic downstaging rate, recurrence-free survival (RFS), overall survival (OS) and neoadjuvant rectal score, among patients who are treated with standard neoadjuvant chemoradiation or TNT, with an aim to investigate how baseline biomarkers and changes in biomarkers with standard therapies may be associated with, and modulate, clinical outcomes.

NCT ID: NCT04417699 Completed - Rectal Cancer Clinical Trials

SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer

SHORT
Start date: July 5, 2022
Phase: Phase 2
Study type: Interventional

TASOX can be safely and efficaciously delivered after short course radiation, resulting in significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local control in appropriately selected stage II/III rectal cancer patients treated with contemporary TME-based surgery.

NCT ID: NCT04411537 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.

NCT ID: NCT04411524 Not yet recruiting - Clinical trials for Locally Advanced Rectal Cancer

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.