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 2026-05-18
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether circulating tumor DNA (ctDNA) testing can help guide chemotherapy before surgery in patients with colorectal or appendiceal adenocarcinoma who have metastatic peritoneal disease. The study aims to determine if ctDNA levels can classify patients as low or high risk for cancer recurrence and assist doctors in deciding the intensity of chemotherapy needed before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC). Participants will have their ctDNA levels measured at the start and during neoadjuvant chemotherapy. This information will be used to tailor the duration of chemotherapy given intravenously before surgery. The study focuses on patients undergoing CRS and HIPEC with curative intent, comparing outcomes based on ctDNA status before treatment. During the trial, patients will undergo blood tests to measure ctDNA and various assessments to monitor treatment response and safety. Researchers will track recurrence-free survival, overall survival, and adverse events over about one year. Additional evaluations include tumor biology, imaging characteristics, and changes in chemotherapy regimens based on ctDNA results. Participation involves ongoing monitoring before and after surgery to understand the impact of ctDNA-guided therapy.
CONDITIONS
Brief 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 of 1 or better
- Adequate organ and marrow function including neutrophil count, platelets, bilirubin, liver enzymes, and creatinine clearance
- Undetectable hepatitis B viral load if infected and on suppressive therapy
- Treated and cured hepatitis C infection or undetectable viral load if on treatment
- No treated brain metastases
- Patients with prior or concurrent malignancies that do not interfere with safety or efficacy assessment
- Cardiac function classified as New York Heart Association Class 2B or better
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- Estimated life expectancy greater than 4 months
- Agreement to use adequate contraception if of child-bearing potential or male participant
- Ability to understand and sign informed consent
- English or non-English speaking capable of participation
You will not qualify if you...
- Unrecovered adverse events from prior anti-cancer therapy greater than Grade 1 toxicity (excluding alopecia)
- Receiving other investigational agents
- Presence of brain or other visceral metastases at investigator discretion
- Uncontrolled intercurrent illness
- Psychiatric or social conditions limiting compliance
- Pregnancy or breastfeeding
- Major surgery within last 4 weeks without adequate recovery
- Serious symptomatic chemotherapy-related adverse events requiring prolonged break over 6 weeks
- Any condition, therapy, or lab abnormality that may interfere with study participation or safety according to the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of neoadjuvant chemotherapy as directed by ctDNA measurements
Participants receive neoadjuvant chemotherapy tailored by circulating tumoral DNA levels measured at the start and during treatment to guide therapy duration.
Visits during neoadjuvant treatment to monitor ctDNA and direct therapy
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here