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Rectal Neoplasms clinical trials

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NCT ID: NCT04850027 Recruiting - Rectal Cancer Clinical Trials

MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

NCT ID: NCT04842006 Recruiting - Colorectal Cancer Clinical Trials

Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

SYNCOPE
Start date: December 20, 2021
Phase: N/A
Study type: Interventional

Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal cancer (CRC) patients these days is almost exclusively driven by the occurrence of the metastatic form of the disease. The treatment of rectal cancer often includes a long delay between diagnosis and the initiation of systemic chemotherapy, increasing risk for systemic metastases for those at high risk. On the other hand, the waiting time during pretreatment before surgery enables comprehensive systematic characterization of the primary tumor status before the decisions on adjuvant chemotherapy, opening a window to the use of precision in decision-making. In this randomized controlled treatment trial, outcomes of novel precision methods to select right rectal cancer patients for treatment that they need will be compared to conventional treatment. The study aims to reduce over-treatment of those that most likely do not benefit from additional treatments. With the overall aim to reduce metastatic form of the disease, patients with high-risk features will be randomized to a treatment strategy with early systemic control by chemotherapy followed by circulating tumor DNA (ctDNA) and organoid-guided adjuvant therapy, or to conventional treatment strategy. Both state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced to bring future diagnostic models of minimal residual disease and chemoresistance closer to current practice. The outcomes will reveal the clinical benefit of such strategy by recurrence-free survival at highest level of evidence, and produce important clinical outcome data on the application of ctDNA in everyday cancer treatment practice. The translational data on the use of ctDNA organoids to inform treatment decision and regimen selection will build knowledge of the use of such biomarkers as tools for clinical practice and clinical research. The results will be scalable worldwide in the practice of rectal cancer treatment.

NCT ID: NCT04827732 Recruiting - Clinical trials for Recurrent Rectal Cancer

Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer

IMPARC
Start date: May 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.

NCT ID: NCT04804956 Recruiting - Rectal Cancer Clinical Trials

Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer

BIORECTUM
Start date: April 1, 2021
Phase:
Study type: Observational

The equilibrium of intestinal microorganisms is essential for health an imbalance has been associated with an increased risk in the development of different pathologies; including colorectal cancer. Rectal cancer is the third most common neoplasm worldwide and the complete excision of the mesorectum is a major prognostic factor. The identification of microorganisms in the adipose tissue that surrounds the small intestine in inflammatory diseases, together with bacterial alterations found in colonic mucosa and feces in patients with rectal cancer in comparison with healthy individuals indicates that microbiome alteration plays an essential role in pathogenesis. The mesorectal microbiome in rectal cancer patients stills unknown and given its importance in the prognostic of the disease the goal of this study is to identify microbial profiles that allow predicting rectal cancer patients with a poor prognosis.

NCT ID: NCT04801511 Recruiting - Rectal Cancer Clinical Trials

Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer

CORT
Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of preoperative chemoradiotherapy (IMRT) with concurrent high-dose intravenous vitamin C and mFOLFOX6 in locally advanced rectal cancer patients.

NCT ID: NCT04777162 Recruiting - Gastric Cancer Clinical Trials

Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

Start date: March 2021
Phase: Phase 2
Study type: Interventional

Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.

NCT ID: NCT04755920 Recruiting - Clinical trials for Colorectal Neoplasms

SGM-101 in Colorectal Brain Metastases.

SGM-CBM
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

NCT ID: NCT04751149 Recruiting - Rectal Cancer Clinical Trials

Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection

RAOREC
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

DESIGN: Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio. POPULATION: Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason. OBJECTIVES: The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection. Secondary objectives are: 1. Incidence of urinary tract infection after urinary catheter removal. 2. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus). 3. Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. DESCRIPTION OF THE INTERVENTION: In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.

NCT ID: NCT04749381 Recruiting - Rectal Cancer Clinical Trials

The Role of TCM on ERAS of Rectal Cancer Patients

RCT
Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.

NCT ID: NCT04749108 Recruiting - Clinical trials for Locally Advanced Malignant Neoplasm

Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma

GRECCAR14
Start date: November 26, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).