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ctDNA-Guided Therapy for Colorectal Cancer
N/A
Recruiting
Led By Michael White, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests ctDNA in the blood to determine if a patient's cancer is likely to return and which treatments are best.
Who is the study for?
This trial is for adults over 18 with moderate or poorly differentiated appendiceal or colorectal adenocarcinoma, visible metastatic peritoneal disease, and good performance status. They must have adequate organ function and not be pregnant, agreeing to use contraception. Excluded are those with recent chemotherapy/radiotherapy, uncontrolled illnesses, major surgery within the last month, brain metastases, or other conditions that could affect study participation.
What is being tested?
The study tests if ctDNA levels before cytoreductive surgery can predict cancer recurrence risk in patients with colorectal or appendiceal adenocarcinoma. This helps determine the intensity of neoadjuvant chemotherapy needed prior to surgery.
What are the potential side effects?
While specific side effects aren't listed for ctDNA testing itself, associated chemotherapeutic agents (5-fluorouracil, oxaliplatin, leucovorin, irinotecan) may cause fatigue, nausea/vomiting/diarrhea (digestive issues), lowered blood cell counts leading to increased infection risk and bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Circulating tumoral DNA directed neoadjuvant therapy armExperimental Treatment1 Intervention
Participants will have their circulating tumoral DNA levels measured at the onset of neoadjuvant chemotherapy and during their neoadjuvant treatment to direct the duration of therapy provided.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,200 Total Patients Enrolled
Michael White, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can communicate in English or another language.My cancer has spread to my brain.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I had major surgery less than 4 weeks ago and haven't fully recovered.I have recovered from side effects of previous cancer treatments, except for hair loss.I have another cancer that won't affect this treatment's safety or results.My cancer has spread to the lining of my abdomen and can be seen during a laparoscopy.My blood counts and organ functions are within the required ranges.My heart function is classified as class 2B or better according to NYHA.I had severe side effects from chemotherapy that needed a break in treatment for more than 6 weeks.My cancer started in the appendix or colon and was initially operable.I am 18 years old or older.I agree to use birth control during the study.My hepatitis B virus load is undetectable with treatment.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.I am mostly able to carry out my daily activities.I had hepatitis C but am now cured, or I am being treated with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Circulating tumoral DNA directed neoadjuvant therapy arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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