Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metast… (NCT03844620) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
United States100 participantsStarted 2019-01-29
Plain-language summary
This phase II trial studies circulating cell-free tumor DNA testing to guide treatment with regorafenib or TAS-102 in patients with colorectal cancer that has spread to other areas of the body. Studying samples of blood from patients with colorectal cancer may help doctors understand how well patients respond to treatment. Regorafenib and TAS-102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well ctDNA testing works in guiding treatment with regorafenib and TAS-102 for patients with advanced or metastatic colorectal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed colorectal cancer.
* Patients must have advanced or metastatic disease with no curative options.
* Patients must have radiographically evaluable disease.
* Patients must have had at least 2 prior therapies for mCRC (including fluorouracil \[5-FU\], oxaliplatin, irinotecan, bevacizumab; cetuximab/panitumumab \[for RAS wild type (WT) patients\]) and have either progressed on or intolerant to these agents or use of these agents is contraindicated.
* Patients must be clinically eligible for either regorafenib or TAS-102 as per their treating physician.
* Patients must have a negative serum pregnancy test done less than are equal to 14 days prior to randomization for women of childbearing potential only. Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation.
* Patients must have ability to complete questionnaire(s) by themselves or with assistance.
* Patients must have ability to provide informed written consent.
* Patients must be willing to return to enrolling institution for follow-up as per study schedule.
* Patients must be willing to provide blood samples for correlative studies.
* Any of the following: Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
* Co-morbid systemic illnesse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC)
Timeframe: First 4 months after treatment initiation
2
Treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity, intolerable grade 2 toxicity, or any toxicity requiring dose reduction) between arms
Timeframe: First 4 months after treatment initiation