Status and phase
Conditions
Treatments
About
This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer.
The interventions involved in this study are:
Full description
This is a Phase I/II clinical trial. Patients are being asked to participate in the Phase I portion of the study. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has approved Trifluridine as a treatment option for this disease.
The FDA has not approved Trifluridine in combination with radiation therapy as a treatment option for this disease.
In this research study, the investigators are determining the safest and most effective dose of Trifluridine in combination with radiation therapy in participants with hepatic metastases from colorectal cancer.
Trifluridine stops DNA replication which may prevent the cancer cells from growing. Radiation may help to kill the cancer cells while protecting normal tissue cells. Studies have shown Trifluridine may make radiation more effective.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participants must have biopsy-proven diagnosis of a colorectal cancer with 1-4 liver metastases. There is no upper size limit and participants must have at least 800 mL of uninvolved liver. Liver metastases may be diagnosed by imaging alone, no liver biopsy is required. Extrahepatic disease is allowed if 1) it has been stable for 3 months prior to study entry, 2) the dominant disease burden is intrahepatic and 3) the patient is referred for definitive radiation therapy to the disease in the liver.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan. See Section 13 for the evaluation of measurable disease.
Participants may have had prior chemotherapy, targeted biological therapy (i.e. sorafenib), surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as the prior therapy occurred more than 3 weeks before the first radiation treatment. Patients may not have had prior liver directed radiation, including radioembolization.
Participants must be 18 years of age or older.
Because no dosing or adverse event data are currently available on the use of high dose liver radiation in participants <18 years of age, children are excluded from this study.
Expected survival must be greater than three months.
ECOG Performance Status 0 or 1..
Participants must have liver metastases deemed unresectable due to anatomy, medical fitness, or presence of extrahepatic disease.
Participants must have normal organ and marrow function as defined below. History of transfusion is acceptable and transfusions may be given to meet eligibility requirements.
If patient has underlying cirrhosis, only Child-Pugh classification Group A patients should be included in this study. Clinical assessment of ascites and encephalopathy is required. Child-Pugh classification must be determined for all study participants at the time of eligibility analysis. As albumin and PT/INR are required for Child-Pugh classification; these labs should be drawn with other labs required for eligibility analysis. See Appendix B for Child-Pugh classification table.
The effects of radiation on the developing human fetus are known to be teratogenic and the safety of TAS-102 in pregnant women and their fetuses has not been established. Therefore, 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, and for 6 months after stopping study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Ability to take oral medications (i.e. no feeding tube and able to swallow whole)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
56 participants in 1 patient group
Loading...
Central trial contact
Tarin Grillo; Theodore S Hong, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal