Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- K-RAS Mutation
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.
Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.
A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.
Investigators
Dae Kyung Sohn
Principal Investigator
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •Age: 20-80 years
- •Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
Exclusion Criteria
- •Patients with distal metastases confirmed at diagnosis
- •Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
- •If patients do not agree with this study
Outcomes
Primary Outcomes
K-RAS Mutation
Time Frame: 4 weeks
K-RAS Mutation status
Secondary Outcomes
- Radiomics - MR image findings(4 weeks)