Status:
ENROLLING_BY_INVITATION
Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Brief Summary
The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a gre...
Detailed Description
It is a prospective phase II, non-randomized controlled designed clinical study. For the optimal design, 58 cases of low rectal adenocarcinoma without metastasis were divided into queue 1 and queue 2 ...
Eligibility Criteria
Inclusion
- Histologically confirmed as rectal adenocarcinoma.
- MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
- The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
- MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
- No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
- Age: 18 \~ 80 years old.
- ECOG score: 0-1.
- Expected life: more than 3 years.
- Hematology: WBC \> 3 × 109/L; PLT\>80 × 109/L; Hb\>90g/L.
- Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
- Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
- Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.
Exclusion
- There are any conditions that make MRI impossible.
- There are serious medical complications.
- Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
- Any unstable condition or situation that may endanger patient safety and compliance.
- Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
- Refuse to sign informed consent.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05338866
Start Date
January 1 2022
End Date
December 31 2033
Last Update
November 22 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060