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Rectal Neoplasms clinical trials

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NCT ID: NCT05254327 Recruiting - Rectal Cancer Clinical Trials

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001

Start date: August 15, 2022
Phase: Phase 2
Study type: Interventional

In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.

NCT ID: NCT05253846 Active, not recruiting - Clinical trials for Locally Advanced Rectal Cancer

Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29

ShorTrip
Start date: January 25, 2022
Phase: Phase 2
Study type: Interventional

The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.

NCT ID: NCT05245786 Recruiting - Clinical trials for Locally Advanced Rectal Carcinoma

An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

Start date: August 31, 2022
Phase: Early Phase 1
Study type: Interventional

This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.

NCT ID: NCT05245565 Recruiting - Rectum Cancer Clinical Trials

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Start date: May 1, 2021
Phase:
Study type: Observational

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer. PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

NCT ID: NCT05245474 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

NCT ID: NCT05241574 Recruiting - Rectal Cancer Clinical Trials

Planned Non-operative Management for Rectal Cancer

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. The aim of this study is to test a hypothesis that escalation of either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads to an increase of clinical complete response rate. The planned sample size of 23 patients was calculated based on the assumption that clinical complete response rate after routine preoperative radio(chemo)therapy is 34% [1] and expected rate after radio(chemo)therapy dose escalation is 75% [2-4]. An endorectal high dose rate iridium brachytherapy boost (2 fractions of 10 Gy) will be added after the routine preoperative treatment consisted of external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to avoid severe post-radiation toxicity.

NCT ID: NCT05233787 Recruiting - Rectal Cancer Clinical Trials

Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)

GRECCAR17
Start date: March 24, 2022
Phase: N/A
Study type: Interventional

GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses. The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery.

NCT ID: NCT05228431 Recruiting - Clinical trials for Advanced Rectal Cancer

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Start date: March 2, 2022
Phase: Phase 2
Study type: Interventional

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.

NCT ID: NCT05216653 Active, not recruiting - Clinical trials for MSS Locally Advanced Rectal Adenocarcinoma

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)

Start date: April 7, 2022
Phase: Phase 2
Study type: Interventional

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

NCT ID: NCT05215535 Recruiting - Rectal Cancer Clinical Trials

Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.

Limerick
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer.