View clinical trials related to Rectal Cancer.
Filter by:A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer
Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE). A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure. The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer. The main question it aims to answer are: • How frequently does LE allow for rectum preservation? Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.
The TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach. The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life & hospital anxiety and depression will be measured.
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
The goal of this observational study is to learn about the T1 relaxation time and T1 relaxation time properties of the disease in people with locally advanced rectal cancer. The main question it aims to answer is: Does MRI T1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer? Participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.
The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are: - Does the use of ICG increase the total number of harvested lymph nodes? - Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes? Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.
Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs. In view of the shortcomings of the current otal neoadjuvant therapy model for locally advanced ultra low rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 8 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy for the poplation who can be achieved organ preservation.
This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.