A Phase 1/2 interventional study of TAS-102 and Photon SBRT in Colorectal Cancer, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Treatment
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:
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 52 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
* Photon treatments will be performed on a linear accelerator * Photon SBRT will be given during TAS-102 dosing * TAS-102 dosing occurs on days 1 through 5 and 8 through 12 * TAS-102 tablets should be taken twice a day orally
Drug: TAS-102 · Radiation: Photon SBRT
Trifluridine stops DNA replication which may prevent the cancer cells from growing
Also known as: Lonsurf, Trifluridine
SBRT stands for Stereotactic Body Radiation Therapy. Radiation may help to kill the cancer cells while protecting your normal tissue cells
Maximum Tolerated Dose (MTD)
MTD will be determined using a 3 + 3 dose escalation. 3 participants enrolled at the starting dose of 20 mg/m2 BID (Bis in die, Latin for twice daily). Based on the number of dose limiting toxicities (DLT), the dose can be either be increased to 25 mg/m2 BID then 30 mg/m2 BID or it could be reduced to 15 mg/m2 BID. * If 0 out of 3 have DLT, enroll 3 participants at next dose level * If ≥ 2 DLT out of 3 or 6 participants in a dose cohort have DLT, this will be the MTD and 3 additional participants are enrolled at next lowest dose if only 3 were treated at that level so far. * If 1 out of 3 have DLT, 3 more enrolled at current dose level. If no DLT in those 3, move to next dose level. If ≥ 1 DLT, declare this the MTD and enroll 3 additional at next lowest dose if only 3 treated so far. * If ≤ 1 out of 6 DLT at highest dose level below maximally administered dose, MTD is generally the rerecorded phase 2 dose (RP2D). Dose level 3 is RP2D if MTD not reached.
Time frame: From start of treatment until 4 weeks after the end of treatment
The Duration of Local Control
Local control is the absence of local failure defined as evidence of tumor growth/regrowth that meets Response Evaluation Criteria In Solid Tumors (RECIST) criteria for progressive disease in any direction beyond that present in pre-treatment imaging studies of the treated lesion(s). The duration of local control will be measured from the start date of protocol treatment until the date of local failure. * Marginal failure is defined as appearance of tumor growth at the margin of the target volume. * Nodal failure is defined as failure in regional lymph nodes (i.e. porta-hepatis, para-aortic, diaphragmatic). * Distant failure is defined as appearance of tumor at sites beyond marginal and regional nodal sites. * Intrahepatic recurrence is defined as any new lesion elsewhere in the liver and separate from local failure.
Time frame: Baseline, 1 month post treatment, every 6 months for two years or until death
Toxicity associated with TAS-102 combined with SBRT
Summary of the Adverse events experienced during treatment. Adverse events are assessed with Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Time frame: From start of treatment until 4 weeks after the end of treatment
Progression Free Survival
Progression-free survival (PFS) will be measured from the start date of protocol treatment (first TAS-102 dose and/or first SBRT fraction) to the earlier date of first failure at any pre-treatment or new site (defined in 'Duration of Local Control' section) or death. PFS will be censored at the date of last follow-up for participants still alive who have not failed.
Time frame: from the start of treatment until 2 years, or until time of progression/death
Overall Survival
Overall survival (OS) will be measured from the start date of protocol treatment (first TAS-102 dose and/or first SBRT fraction) to the date of death. OS will be censored at the date of last follow-up for participants who are still alive.
Time frame: from the start of treatment until 2 years, or until time of death
Association between KRAS or BRAF mutation status with local control
Association between KRAS or BRAF mutation status with local control will be assessed using Gray's test with death as a competing risk in the absence of local failure. Local control is defined in the 'Duration of Local Control' description.
Time frame: Baseline, 1 month post treatment, every 6 months for two years or until death
Serial ctDNA
Serial ctDNA will be analyzed by descriptive methods to identify potential trends and correlations with synchronous radiologic endpoints (baseline, one month post-treatment). ctDNA level (detectable versus negative) at early (week 1, week 2) and post-treatment (one month) assessments will be analyzed for differences in local control
Time frame: Baseline, week 1, week 2, 1 month post treatment, at the time of progression
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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