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Rectal Neoplasms clinical trials

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NCT ID: NCT06162650 Recruiting - Rectal Cancer Clinical Trials

Total Neoadjuvant Therapy in Rectal Cancer

Start date: November 16, 2023
Phase: Phase 2
Study type: Interventional

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

NCT ID: NCT06149741 Recruiting - Rectal Cancer Clinical Trials

Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer

STOMALEFT
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This is prospective, multi centre study evaluating a novel type of defunctioning loop stoma after low anterior resection for rectal cancer. Patients will be operated with a complete splenic flexure mobilisation and total mesorectal excision. An anastomosis will be fashioned at the pelvic floor. This will leave a redundant colon which will be brought up and matured in the left iliac fossa. Patient bowel function and quality of life will be monitored at baseline and at one year postoperatively, when the stoma will typically have been reversed. Dehydration and kidney injury are expected to become infrequent in comparison with the main alternative loop ileostomy. About 20 patients will be included in this pilot study.

NCT ID: NCT06116019 Recruiting - Prostate Cancer Clinical Trials

Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

ART-02
Start date: October 11, 2023
Phase:
Study type: Observational

The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian/SHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).

NCT ID: NCT06108596 Recruiting - Clinical trials for Locally Advanced Rectal Adenocarcinoma

Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and CAPOX in Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer - a Single-center, Single-arm, Open-label Clinical Trail

Start date: December 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Evaluation of the efficacy and safety of interleucin-2 combined with PD-1 monoclonal antibody and CAPOX in preoperative neoadjuvant therapy for locally advanced rectal cancer - a single-center, single-arm, open-label clinical trail.

NCT ID: NCT06096493 Recruiting - Rectal Cancer Clinical Trials

Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

Start date: May 1, 2023
Phase:
Study type: Observational

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

NCT ID: NCT06082648 Recruiting - Rectal Neoplasms Clinical Trials

Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.

NCT ID: NCT06056726 Recruiting - Rectal Cancer Clinical Trials

Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

Start date: February 18, 2021
Phase:
Study type: Observational

Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss. Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

NCT ID: NCT06052332 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Efficacy and Safety of SCRT Versus TNT in Older Patients With Locally Advanced Rectal Cancer

SHAPERS
Start date: February 7, 2024
Phase: N/A
Study type: Interventional

The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.

NCT ID: NCT06050447 Recruiting - Colorectal Cancer Clinical Trials

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.

NCT ID: NCT06043999 Recruiting - Rectal Cancer Clinical Trials

Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors. However, the local recurrence caused by non-TME surgery is still the focus of concern for clinicians and patients. Previous retrospective studies have shown that there is no significant difference in overall survival and disease free survival between salvage CRT group and salvage TME group for patients with early rectal cancer after local resection. Pathological pT2 after local resection is the only independent risk factor for disease-free survival. However, limited to a single center and small sample size, the recurrence caused by salvage radiotherapy and chemotherapy should still be alert. Given these concerns, there is an urgent need to identify a better treatment regimen that can ensure reliable oncologic outcomes after local resection. Therefore, with TME as the control group and salvage chemoradiotherapy as the experimental group, we conducted a prospective, randomized, multicenter, non-inferiority clinical trial of the treatment effect of patients with intermediate-risk T1 and clinical stage N0M0 rectal cancer after local resection, to provide high-level evidence-based medical evidence for the final choice of these two salvage treatment methods.