Rectal Cancer
Conditions
Interventions
Observation Group:None
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age greater than 18 years and less than 75 years; 2) physical condition ECOG score 0-1; (see Annex 1 for evaluation criteria) 3) Pathologically confirmed adenocarcinoma of the rectum; 4) Lower tumor margin = 12 cm from the anal verge (endoscopy) or = 8 cm from the anorectal ring (ARJ); 5) Receive neoadjuvant therapy or concurrent radiotherapy, and be considered to be in complete clinical remission after treatment (the criteria for complete clinical remission are mainly based on the evaluation criteria of the "Chinese Collaborative Working Group on Waiting and Watching Database for Neoadjuvant Therapy of Rectal Cancer (CWWD)" (see Annex I), and have a waiting and watching strategy. 6) No evidence of distant metastasis before or after radiotherapy; 7) No severe constipation, and can defecate for intestinal flora testing during the review follow-up period; 8) Blood count: ANC>1.5 cells/mm^3, HGB>9.0 g/dL, PLT>100,000/mm^3; 9) Blood biochemistry: total bilirubin =1.5xULN, AST =2.5xULN, ALT =2.5xULN; 10) Serum creatinine =1.5x upper limit of normal and endogenous creatinine clearance =50mL/min (Cockcroft-Gault formula); 11) International Normalized Ratio (INR), activated partial thromboplastin time (aPTT) = 1.5 times upper limit of normal (only for patients not receiving anticoagulation; patients receiving anticoagulation should keep anticoagulants within therapeutic requirements); 12) Normal cardiac function, i.e., normal electrocardiogram or abnormalities that are not clinically significant, and left ventricular ejection fraction (LVEF) greater than 50% on cardiac ultrasound; 13) The patient reads, signs and agrees to participate in this study by signing the informed consent form; 14) Patients voluntarily enroll in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. It is recommended that all patients provide tumor tissue specimens for genetic testing before enrollment. 15) Reproductively active males or females with the possibility of pregnancy must use highly effective contraceptive methods throughout the waiting period for observation and continue to use contraception for 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1) Recurrent rectal cancer; 2) the patient has had another malignancy within the last 5 years (except properly treated basal cell carcinoma and squamous skin cancer); 3) The patient is a pregnant or breastfeeding woman; 4) the patient has other comorbid medical conditions or mental status abnormalities that may affect the patient's participation in this study; 5) Has any uncontrolled clinical problems, including but not limited to: a Persistent or active (severe) infection; b poorly controlled hypertension (blood pressure persistently greater than 160/100 mmHg) on medication c poorly controlled diabetes; d heart disease (class III/IV congestive heart failure or heart block as defined by the New York Heart Association);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Regrowth; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor recurrence;Distant metastases; | — |
Countries
China
Contacts
Public ContactWang weihu
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute
Outcome results
None listed