Status:
UNKNOWN
A Prospective Study Utilizing Circulating Cell Free DNA (cfDNA) Use in the Detection of RAS Mutations in Patients With Advanced Colorectal Cancer.
Lead Sponsor:
National Guard Health Affairs
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Colorectal cancer remains the commonest cancer among men, and third commonest among women in Saudi Arabia . Presentation with metastatic disease occurs in almost one third of patients , with 5-year su...
Detailed Description
Colorectal cancer remains the commonest cancer among men, and third commonest among women in Saudi Arabia . Presentation with metastatic disease occurs in almost one third of patients , with 5-year su...
Eligibility Criteria
Inclusion
- Adult patients aged \>18 years who are diagnosed histologically with advanced/ metastatic colorectal adenocarcinoma.
- Primary disease must be in left side of colon.
- ECOG performance status of \</= 2.
- The primary treating physician believes that the patient has a life expectancy of more than 3 months at enrollment.
- Tumor characteristics at baseline must be RAS/ BRAF wildtype.
- Must have RECIST measurable disease.
- Metastatic burden \</= 3 organ involvement.
- Adequate bone marrow, liver and renal function assessed within 14 days before starting systemic treatment.
- Signed informed consent before any study specific procedures.
Exclusion
- Patients with peritoneal metastases.
- Life expectancy of less than 3 months in the opinion of the investigator.
- Refusal to consent.
- Past or current history of malignancy other than colorectal carcinoma, except for curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Pregnant women.
Key Trial Info
Start Date :
February 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04775862
Start Date
February 21 2021
End Date
February 1 2024
Last Update
March 1 2021
Active Locations (1)
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1
Ministry of National Guard - Health Affairs
Riyadh, Saudi Arabia