Rectal Cancer
Conditions
Interventions
Gold Standard:Rectal MRI (according to "Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2023 edition)", it is the gold standard imaging method for the diagnosis and evaluation of
Index test:Energy spectrum CT
Sponsors
Department of Radiation Oncology, Peking Union Medical College Hospital, ChineseAcademy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: a) =18 years old; b) Low and medium-level rectal cancer confirmed by histopathology, or suspected of not being diagnosed by pathology, but clinically diagnosed by combination of imaging (at least 2 imaging assessments, such as CT and PET), biomarker assays, and tumor committee protocols (MRI evaluation of the tumor < 12cm from the anal margin); c) Stage II to III rectal cancer diagnosed by rectal MRI or rectal ultrasound (T3-T4 or N+, no distant metastasis) with indications of neoadjuvant therapy and proposed to receive neoadjuvant chemoradiotherapy; d) Surgery is expected after neoadjuvant therapy; e) ECOG score 0-2, expected to be able to lie on the treatment bed for half an hour; f) Normal liver/kidney and blood function; Complete blood counts were obtained within 2 weeks prior to study enrollment, and bone marrow function was normal; The definition is as follows: i. Neutrophil count ANC=1800 cells /mm3 ii. Platelet =100,000 cells/mm3 iii. Hemoglobin =8.0 g/dl iv. Serum creatinine within the normal range or creatinine clearance =50ml /min v. Bilirubin is within normal range vi. AST and ALT < 2.5 x the upper limit of the normal range g) The patient has signed the informed consent for the study before entering the study
Exclusion criteria
Exclusion criteria: a) Men/women of reproductive age who refuse to abstain from sex/contraception in various ways during the study period; b) A history of other concomitant cancers (including synchronous primary colon cancer) in the last 3 years, in addition to carcinoma in situ of the uterus and non-melanoma skin cancer; c) There are contraindications for rectal MRI: metal implants with various MRI contraindications in the body, critically ill patients, claustrophobia, pregnant women and infants, and patients who cannot cooperate; d) Have received surgery, radiotherapy or chemotherapy after diagnosis of rectal cancer; e) Previous history of pelvic radiotherapy; f) Evidence of recurrence or distant metastasis of rectal cancer; g) Allergic to contrast agents/contrast agents; h) Severe, active comorbidity: i. Unstable angina pectoris and/or congestive heart failure within the past 12 months requiring hospitalization ii. Transmural myocardial infarction within the last 6 months iii. Liver insufficiency leading to clinical jaundice and/or blood clotting deficiency iv. Chronic kidney failure v. Acquired Immune deficiency syndrome AIDS based on the current CDC definition vi. Uncontrolled seizures, diseases of the central nervous system, or mental disabilities deemed by the investigator vii. Known uncontrolled coagulation dysfunction. Patients receiving therapeutic anticoagulant therapy may be enrolled if they have been clinically stable on anticoagulant therapy for at least 2 weeks viii. Major surgery was performed within 28 days of enrollment i) participated in any other drug study within 28 days of enrollment; j) Patients who, due to geographical, social and/or physical reasons, are unable to follow up with treatment and regular weekly follow-up as required by the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete response rate;Clinical partial response rate;sensitivity;specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate after radiotherapy;Surgical pathological complete response rate;Surgical pathological partial response rate;Overall survival rate;Progression free survival;Severe adverse reactions occurred after radiotherapy;positive predictive value;negative predictive value; | — |
Countries
China
Contacts
Public ContactKe Hu
Department of Radiation Oncology, Peking Union Medical College Hospital, ChineseAcademy of Medical Sciences and Peking Union Medical College
Outcome results
None listed