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Brief Title: MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer
Official Title: Efficacy of MRI Guided Simultaneous Integrated Boost Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer: a Randomized, Controlled, Phase III Clinical Trial
Study ID: NCT06246344
Brief Summary: Colorectal cancer has an annual incidence surpassing 700,000 cases globally, ranking as the fourth most prevalent cancer with the second-highest mortality rate. Rectal cancer accounts for approximately one-third of newly diagnosed colorectal cancer cases. Stages II (cT3-4/N0) and III (cT1-4/N1-3) rectal cancer are commonly classified as Locally Advanced Rectal Cancer (LARC), characterized by a high risk of local recurrence post-surgery. Neoadjuvant chemoradiotherapy (CRT) combined with Total Mesorectal Excision Surgery (TME) has reduced the 5-year local recurrence rate in LARC from 25% to 5%-10%. Currently, neoadjuvant CRT+TME+postoperative adjuvant chemotherapy effectively controls local recurrence in LARC. However, it is associated with low Pathological Complete Regression (pCR) rates, suboptimal sphincter preservation, increased distant metastasis, heterogeneous adherence to adjuvant chemotherapy, and limited long-term survival benefits. Further optimization of neoadjuvant treatment strategies holds promise for promoting tumor regression and improving prognosis. In neoadjuvant therapy, the extent of rectal tumor regression is highly dependent on radiotherapy, with higher radiation doses correlating with increased rates of pathological regression. This study aims to investigate the role of MRI-guided radiotherapy with a simultaneous integrated boost in enhancing tumor pCR in neoadjuvant treatment for locally advanced rectal cancer.
Detailed Description: MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China