What is ctDNA testing studying for colorectal or appendiceal adenocarcinoma?

This study is evaluating whether blood tests measuring circulating tumor DNA can help identify patients at low or high risk of cancer returning after surgery. Researchers want to see if this can guide how intense chemotherapy should be before surgery. The study is led by M.D. Anderson Cancer Center to improve treatment decisions for this cancer type.

Who may be eligible for this colorectal or appendiceal adenocarcinoma clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of moderate or poorly differentiated colorectal or appendiceal adenocarcinoma and visible metastatic peritoneal disease may be eligible. Both men and women can participate. Participants must have good organ function and performance status. Please review eligibility criteria for more details.

Is there any cost to participate in this colorectal or appendiceal adenocarcinoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend scheduled visits for tests and treatments as part of the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05947838

Study Using Blood Tumor DNA Testing to Guide Chemotherapy Before Surgery for Colorectal or Appendiceal Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-05-18

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Michael White, MD

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Study Using Blood Tumor DNA Testing to Guide Chemotherapy Before Surgery for Colorectal or Appendiceal Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria