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225 active trials for Rectal Cancer

Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)

To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.

Start: April 2021

APEMESH II - Perineal Reconstruction

The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Start: March 2021

Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer

This trial is assessing how Bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer

Start: September 2020

Prevention of Colorectal Cancer Through Multiomics Blood Testing

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Start: May 2020

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.

Start: March 2017

Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.

Start: April 2021

The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume & consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.

Start: May 2021

MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

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

Start: January 2021

The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

It has been reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. In addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. Therefore, the importance of predicting patients with pathological complete response has increased. It has been reported that data obtained from PET-CT scans and clinical information such as tumor size, T stage, and N stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer. Consideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. Because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. There are a limited number of blood biomarkers such as CEA and IL-6 that have been studied in the literature. Experimental studies show that vitamin D suppresses inflammation and protects against cancer by triggering differentiation. In 1980, Cedric and Frank Garland stated for the first time that vitamin D may affect the survival of the patient after the diagnosis of colorectal cancer. In later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin D - 25 (OH) D and survival rates for colorectal cancer, breast and prostate cancer. In addition, 25 (OH) D serum concentration has been shown to be inversely related to colorectal cancer progression. In the light of all these information, the role of serum vitamin D levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.

Start: September 2020

A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer

Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and leads to frequent false positive and negative results. Molecular markers reflecting the initial and post-nCRT status of the tumor would be ideal to select patients eligible for organ preservation. This project will test the detection of tumor extracellular vesicles (EVs) in liquid biopsy as a reliable marker for the identification of poor versus good responders to nCRT.

Start: May 2021

Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Start: October 2019

Rectal Surgery Evaluation Trial (RESET)

Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

Start: October 2018

Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

Start: January 2018

Peptide-based Immunization for Colon- and and Pancreas-carcinoma

An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

Start: April 2019

Induction Chemotherapy for Locally Advanced Rectal Cancer

Despite developments in the multidisciplinary treatment of patients with locally advanced rectal cancer (LARC), such as the introduction of total mesorectal excision (TME) by Heald et al. and the shift from adjuvant to neoadjuvant (chemo)radiotherapy ((C)RT), local and distant recurrence rates remain between 5-10% and 25-40% respectively. Several studies established tumour characteristics with particularly bad prognosis; it was demonstrated that the occurrence of mesorectal fascia involvement (MRF+), grade 4 extramural venous invasion (EMVI), tumour deposits (TD) and enlarged lateral lymph nodes (LLN) lead to high local and distant recurrence rates and decreased survival when compared with LARC without these particularly negative prognostic factors. This type of LARC is described as high risk LARC (hr-LARC). Achieving a resection with clear resection margins (R0) is an important prognostic factor for local (LR) and distant recurrence (DM) as well as survival. With the aim to further reduce the risk of recurrent rectal cancer, to diminish distant metastasis and to improve overall survival for patients with LARC, induction chemotherapy (ICT) became a growing area of research. The addition of ICT has the ability to induce more local tumour downstaging, possibly leading to resectability of previously unresectable tumours, more R0 resections and less extensive surgery. In the case of a complete clinical response, surgery may even be omitted. ICT may also have the potential to eradicate micrometastases. Hence, increased local downstaging and reducing distant metastatic spread may reduce LR and DM rates and improve survival and quality of life. In recent years, the use of ICT was investigated and showed promising results, but little is known about the addition of ICT in patients with high risk LARC. Since these patients have a particularly bad prognosis, both with regard to locoregional and distant failure, a more intensified neoadjuvant treatment with FOLFOXIRI is anticipated to improve short- and long term results.

Start: June 2021

Domestic Surgical Robot Clinical Study

Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. Recently, as the domestic surgical robot research project's main section, this new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University.

Start: January 2015

Lateral Nodal Recurrence in Rectal Cancer

Local recurrence rates in rectal cancer have reduced dramatically since the introduction of the total mesorectal excision (TME) technique and neoadjuvant chemoradiotherapy (CRT) to overall rates of 5-year local recurrence to 5-10%. However, distal rectal cancers have a tendency to spread to lateral lymph nodes and it was recently shown that patients with enlarged lateral lymph nodes of ?7 mm have a considerable chance of a local recurrence, 19.5% in 5 years regardless of CRT with TME. If the enlarged (>7mm) lateral lymph node was reduced to <4mm (internal iliac) or <6mm (obturator), none of the patients developed a local recurrence, while lymph nodes that stayed enlarged in the internal iliac compartment had a local recurrence rate over 5 years of 52.3%. This rate was significantly reduced to 8.7% when performing a lateral lymph node dissection (LLND) to (C)RT + TME. A major drawback of this recent multi-center study is its retrospective nature, for example, while each center has general guidelines for irradiating lateral nodal compartments, it might be possible that these lymph nodes were not always included in the irradiation fields. The LaNoReC trial is a prospective registration study aimed at increasing national awareness for enlarged lateral nodes and their role in local recurrences. The main question of this study is whether, after standardized and quality controlled irradiation of the lateral nodes and selective LLNDs performed in an expertise center, the lateral local recurrence rate in rectal cancers with nodes with a short-axis of ? 7 mm can be reduced to below 6%.

Start: October 2020

The Registry of Oncology Outcomes Associated With Testing and Treatment

This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.

Start: April 2021

Ultrasound and Photoacoustic Imaging of Colon and Rectal Tumor Tissue

The purpose of this pilot study is to a) explore the photoacoustic properties of normal, polypoid, and malignant colorectal tissue and b) demonstrate the functionality of a novel endorectal photoacoustic ultrasound probe in humans with rectal cancer. The study includes two parts. The initial exploratory portion will be conducted ex vivo with resected colon and rectal specimens immediately following surgical excision. Based on those findings, an endorectal probe will then be constructed to examine in vivo tumors. The investigators hypothesize that in vivo photoacoustic imaging will be capable of differentiating normal from malignant tissue.

Start: July 2017

Chemo-radiotherapy as Main Treatment Strategy for Rectal Cancer. Can we Provide a More Precise and Effective Treatment

The purpose of this project is to obtain important information about the tumour and surrounding organs during preoperative chemo-radiotherapy for patients with adenocarcinoma of the rectum. The knowledge generated in this project has the potential to make future radiotherapy treatments (RT) of rectal cancer patients more precise, with less side effects. This could lead the way to make chemo-radiotherapy the main treatment modality and spare a large group of patients from the risk of severe complications after surgery. Specifically, we aim to obtain: A characterization of systematic and random changes in position and shape of tumours and surrounding organs during RT. A patient-specific pre-treatment characterization of random uncertainties in position and shape of the tumour during radiotherapy. This will be used to create and assess an individual, patient-specific treatment strategy, with the possibility to implement an adaptive RT strategy using the information obtained from the MRI-scans during treatment. Information about treatment response and local toxicity from morphological and functional data before, during and after CRT.

Start: June 2018