Actively Recruiting
A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
48
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if circulating tumor DNA (ctDNA) testing before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC) can show if patients have a low or high risk of the disease returning and help doctors decide if less or more intense chemotherapy is needed as treatment before surgery. ctDNA testing measures the amount of tumor DNA (genetic information) in the blood.
CONDITIONS
Official Title
A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed moderate or poorly differentiated appendiceal or colorectal adenocarcinoma with initial resectable disease
- Presence of metastatic peritoneal disease visible on imaging or during laparoscopy
- Age 18 years or older
- ECOG performance status 0 or 1 (Karnofsky 70% or higher)
- Adequate organ and marrow function including neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL, total bilirubin ≤1.5 times institutional upper limit, AST/ALT ≤3 times upper limit, and creatinine clearance ≥30 mL/min
- Undetectable HBV viral load on suppressive therapy if chronic hepatitis B infection present
- Treated and cured hepatitis C infection or undetectable viral load if currently on treatment
- No treated brain metastases
- Previous or concurrent malignancies allowed if they do not interfere with study safety or efficacy
- Cardiac function classified as New York Heart Association class 2B or better
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Life expectancy greater than 4 months
- Agreement to use adequate contraception for women of child-bearing potential and men during and after study participation
- Ability to understand and sign informed consent
- English or non-English speaking
You will not qualify if you...
- Not recovered from prior anti-cancer therapy side effects greater than grade 1 except alopecia
- Currently receiving other investigational agents
- Presence of brain or other visceral metastases as determined by investigator
- Uncontrolled illnesses that may interfere with participation
- Psychiatric illness or social situations limiting compliance
- Pregnant or breastfeeding women
- Major surgery within 4 weeks without adequate recovery
- Serious chemotherapy-related adverse events (grade 3 or 4) causing prolonged treatment breaks over 6 weeks
- Any condition or abnormality that could confound study results or interfere with full participation, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael White, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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