Stage IV Colorectal Cancer AJCC v8 Clinical Trial
Official title:
A Randomized Study Evaluating Tailoring of Advanced/Metastatic Colorectal Cancer (CRC) Therapy Using Circulating Cell-Free Tumor DNA (ctDNA) (TACT-D)
Verified date | January 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Exclusion Criteria: - Patient who have received prior TAS-102 are eligible to enroll on the study if they can receive regorafenib and vice-versa. Otherwise these patients will be excluded from the study. - Congestive heart failure > New York Heart Association (NYHA) class 2, unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 3 months prior to randomization. - Ongoing infection > grade 2 CTCAE version 4.0. - Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to brain lesions at the time of randomization (Note: patient must not be undergoing acute steroid therapy or taper [chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies]). - Renal failure requiring hematological or peritoneal dialysis. - Patients unable to swallow oral medications. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC) | Number of patients with rise in ctDNA level will be compared to Number of patients with progression of disease on scans. | First 4 months after treatment initiation | |
Primary | Treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity, intolerable grade 2 toxicity, or any toxicity requiring dose reduction) between arms | Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. To compare the proportions of patients who have experienced TRAEs of interest within the first 4 months between the two treatment arms, Fisher's exact test will be used. | First 4 months after treatment initiation | |
Secondary | Mean patient-reported outcomes (PROs) score as per MD Anderson Symptom Inventory (MDASI-GI) | Mean PROs scores measured by MDASI-GI scales will be compared between arms | Up to 18 months | |
Secondary | Mean patient-reported outcomes (PROs) score as per PRO-CTCAE | Mean PROs scores measured by PRO-CTCAE scales will be compared between arms | Up to 18 months | |
Secondary | Percentage of patients with partial response (PR) | Percentage of patients with PR will be compared between arms | Up to 18 months | |
Secondary | Percentage of patients with stable disease (SD) | Percentage of patients with SD will be compared between arms | Up to 18 months | |
Secondary | Overall survival (OS) | OS will be compared between arms. | Up to 18 months | |
Secondary | Percentage of patients who present with events of special interest (ESIs) | Percentage of patients who present with ESIs [described as either Hospitalizations/emergency room visits or need for medical interventions (blood transfusions and IV hydration)] will be compared between arms | Up to 18 months | |
Secondary | Cost measured in US dollars | Cost measured in US dollars will be compared between arms | Up to 18 months | |
Secondary | Median time to performance status deterioration | Will be compared between arms. | Up to 18 months | |
Secondary | Median time to PRO deterioration | Will be compared between arms. | Up to 18 months | |
Secondary | Proportion of patients referred to clinical trial | Will be compared in both arms. | Up to 18 months |
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