Clinical Research Directory

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer

The goal of this clinical trial is to learn whether a modified single-stapled anastomosis (MST) can reduce anastomotic leakage compared with the conventional double-stapled technique (DST) in adult patients undergoing laparoscopic or robotic low anterior resection for rectal cancer. The main questions it aims to answer are: * Does MST lower the incidence of anastomotic leakage after rectal cancer surgery? * Does MST improve short-term surgical outcomes compared with DST? Researchers will compare the MST group with the DST group to see if MST leads to fewer anastomotic leaks and safer postoperative recovery. Participants will: Receive either MST or DST during minimally invasive rectal cancer surgery Undergo routine postoperative CT scans within one month after surgery to check for symptomatic or asymptomatic anastomotic leakage Attend scheduled follow-up visits and standard postoperative assessments as part of routine rectal cancer care

A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer

This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm.

Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study

Study Description This prospective, controlled clinical study aims to compare the clinical outcomes of reinforced anastomosis using 8-10 interrupted sutures versus the conventional Dixon procedure in patients undergoing laparoscopic low anterior resection for low rectal cancer. Anastomotic leakage remains one of the most significant postoperative complications following low rectal cancer surgery, particularly in laparoscopic procedures due to limited tactile feedback and maneuverability in the pelvic cavity. Reinforcement of the anastomotic site through additional interrupted suturing may provide better mechanical strength and improved healing, potentially reducing the incidence of anastomotic leakage and related morbidities. In this study, eligible patients will be assigned to receive either a conventional laparoscopic Dixon procedure or the same procedure with added reinforcement of the anastomosis using 8-10 interrupted sutures circumferentially. Perioperative outcomes including the rate of anastomotic leakage, postoperative complications, operation time, length of hospital stay, return of bowel function, and quality of life will be assessed and compared between the two groups. The study seeks to provide evidence for optimizing surgical techniques in low rectal cancer treatment and improving patient prognosis.

Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. About 1 in 4 people with CRC already have cancer spread (metastasis) when first diagnosed, and about half develop spread during their illness. Recent research shows that bacteria living in the gut and even within tumors might play an important role in how cancer spreads. The goal of this study is to better understand how bacteria might influence the spread of colorectal cancer. The main questions the investigators aim to answer are: Are there differences in bacteria between people whose cancer has spread and those whose cancer has not spread? Could certain bacteria help predict which cancers might spread? To answer these questions, the investigators will: Collect different types of samples from participants: Tumor tissue Normal tissue near the tumor Tissue from where cancer has spread Stool samples before surgery Study the bacteria in these samples using advanced testing methods Compare bacterial patterns between different groups People can take part in this study if they: Are between 18 and 75 years old Have colorectal cancer confirmed by doctors Have not taken antibiotics recently Do not have immune system problems This research may help us: Understand why some colorectal cancers spread Find new ways to predict which cancers might spread Develop better treatments for colorectal cancer

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer

Rectal cancer (RC) is among the most prevalent gastrointestinal cancers \[1\], characterized by significant tumor heterogeneity \[2\]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer \[3\]. Although the locoregional recurrence rate has decreased due to this treatment, distant metachronous metastases still occur in over 20-30% of cases \[4,5\]. The varying biological characteristics of rectal cancer may result in different treatment responses and prognoses \[6\]. Patients who are diagnosed with the same tumor-node-metastasis (TNM) stage of RC frequently exhibit vastly different clinical outcomes, despite receiving the same therapeutic interventions \[7\]. While the TNM staging system remains the predominantly used framework for directing treatment choices and forecasting prognosis, it is crucial to take into account additional pathological elements, such as tumor budding, lymphovascular invasion (LVI), perineural invasion, and extramural venous invasion \[8-10\]. A recent investigation has highlighted that LVI, rather than the traditionally prioritized extent of tumor invasion, serves as a significant risk factor for metastasis in early-stage RC \[11\]. Patients exhibiting LVI+ demonstrate a considerably worse prognosis and overall survival when compared to those with LVI -. Identifying LVI before surgery is crucial for informing treatment strategies in RC \[12\]. LVI offers important information regarding the tumor's biological behavior and its likelihood of metastasizing, thus improving the precision of disease staging. This information enables clinicians to tailor treatment approaches, which helps prevent overtreatment in patients with LVI -. In cases where LVI is present, it may be essential to adopt more aggressive treatment methods, such as postoperative chemotherapy, radiotherapy, or more extensive surgical resections, to reduce the chances of recurrence and metastasis. In summary, LVI serves as a crucial prognostic factor, providing essential insights into the tumor's potential for metastasis and recurrence, which has significant clinical implications for predicting postoperative outcomes, including recurrence, metastasis, and disease-free survival. Therefore, a preoperative non-invasive assessment of LVI, particularly in patients with LVI +, may be instrumental in guiding clinical practice. Conventional magnetic resonance imaging (MRI) is particularly effective in observing large blood vessels and has moderate sensitivity and high specificity to distinguish LVI \[13\]. However, it can noninvasively and accurately assess extramural vascular invasion with a diameter greater than 3 mm. In contrast, it is challenging to evaluate vascular invasion with a diameter less than 3 mm, as well as intramural vascular and lymphatic infiltration, due to the limitations in resolution \[14,15\]. In addition, pathological biopsy is the gold standard for preoperative diagnosis. However, this invasive approach may not reflect the LVI status of the entire tumor due to possible sample errors \[16\]. Therefore, effectively assessing LVI in RC via preoperative imaging remains a significant challenge. Intravoxel incoherent motion (IVIM) is a functional imaging method that can display the diffuse movement of water molecules and blood flow, microcirculation perfusion, thereby improving the diagnostic accuracy of RC \[17,18\]. The IVIM model has the potential to identify perfusion effects using multiple b-value samples and biexponential curve fit analysis \[19\], which can lead to three parameters, namely the true diffusion coefficient (D), the pseudo-diffusion coefficient (D\*), and the perfusion fraction (f). Li et al \[20\]. discovered that the D value obtained from IVIM of LVI+ patients was significantly higher than that of LVI- patients with RC, but only 42 patients were included in this study, making it more difficult to accurately assess the feasibility of IVIM. In another study, Kan et al \[21\]. revealed that the D value was helpful to assess the prognostic factor related to RC, while the AUC of the D value for evaluating LVI was only 0.646. Currently, studies utilizing conventional IVIM quantitative parameters have demonstrated a relatively low diagnostic efficiency in detecting LVI, with AUC values ranging from 0.629 to 0.646 \[22,23\]. Tumor heterogeneity has emerged as a significant biomarker for tumor staging and prognosis \[24\]. Sub-region analysis, an innovative imaging post-processing technique, has demonstrated its potential in exploring intratumor heterogeneity in recent years. Prior research has underscored the importance of sub-region analysis derived from either single-modality or multiparametric MRI in the investigation of intratumor heterogeneity in RC \[25-27\]. However, to our knowledge, the application of sub-region analysis based on IVIM-MRI to evaluate LVI status and prognosis in patients with RC has not been reported. Thus, this study aimed to assess the fe

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%). Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma. Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.

SCRT in TNT With or Without Chlorophyllin

The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer. This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment. Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.

Local Recurrence Due to Rectal Cancer in Sweden

The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined. We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.

Study for Wait and Watch Suitable in Rectal Cancer

One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy \& chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, investigators are only going to observe the patient's response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.

Short-course Radiotherapy or Long-course Chemoradiation Followed by MFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer

Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to minimize or circumvent the organ dysfunction and subsequent decline in quality of life associated with radical surgery, with improving disease-free survival (DFS), while . Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer.

RATME Vs LATME in Middle and Low Rectal Cancer

This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.

Development of a Clinical and Biological Database in Rectum Cancer

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.

Non-operative Management for Locally Advanced Rectal Cancer

This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.

Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.

Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial

Study Purpose: This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care. Background: Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2) Current Knowledge: Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery. Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5) Need for the Study: There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most. Study Design: This study is a randomized controlled trial that will: * Compare PFR to usual care in patients after LAR surgery. * Focus on bowel control and quality of life. * Provide detailed insights to improve aftercare for rectal cancer patients.

Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

Selection of Surgical Technique in Rectal Cancer

Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes. Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.

MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer

Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.