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Completed
NCT05609149
MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer
Conditions: Rectal Cancer
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 480
Sponsor: Sun Yat-sen University
Location: China
Summary
This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.
Eligibility Criteria
Inclusion Criteria:Underwent primary rectal adenocarcinoma resectionReceived MRI scan before surgeryWilling and able to provide written informed consent for participation in this study.Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (<12 cm from the anal verge).Clinical stage of T3Nx or T1-3N+ at initial diagnosisNon-complicated primary tumor (complete obstruction, perforation, bleeding).Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Exclusion Criteria:Treated with transanal local excisionwith distant metastases at the time of initial diagnosisSubjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.Subjects with a history of any arterial thrombotic event within the past 6 months.
This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).
Source: ClinicalTrials.gov (NCT05609149). StuddyBuddy aggregates publicly available trial information.