Status:
UNKNOWN
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Lead Sponsor:
Jing Jin, M.D.
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Detailed Description
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify t...
Eligibility Criteria
Inclusion
- Rectal adenocarcinoma confirmed by histopathology
- MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
- The age is 18-75 years old, no gender limit
- 3\) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Exclusion
- History of other malignant tumors;
- They were allergic to 5-FU, platinum, etc;
- The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
- After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
- History of gastrointestinal fistula, perforation or severe ulcer;
- At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04664504
Start Date
December 1 2020
End Date
December 1 2025
Last Update
June 8 2021
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China, 100021