CLINICAL TRIAL

TAS-102 for Colorectal Cancer

Metastatic
Recruiting · 18+ · All Sexes · Boston, MA

Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer

See full description

About the trial for Colorectal Cancer

Eligible Conditions
Colorectal Carcinoma (CRC) · Colorectal Neoplasms

Treatment Groups

This trial involves 2 different treatments. TAS-102 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Photon SBRT
RADIATION
TAS-102
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-102
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who want to participate in this study must have a disease that can be measured accurately show original
Participants may have had prior chemotherapy, 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 show original
Children are not allowed to participate in this study because there is no information on how radiation treatment affects the liver in people who are younger than 18 years old. show original
ECOG Performance Status 0 means that a person is completely healthy show original
Candidates for the study must have liver metastases that are considered unresectable due to their location, the health of the patient, or the presence of tumors outside of the liver. show original
People who want to participate in this study must have normal organ and marrow function as defined in the following criteria show original
People with a colorectal cancer that has spread to the liver and who have at least 800 milliliters of healthy liver tissue are eligible for this study show original
People must be at least 18 years old to participate. show original
The expected survival must be greater than three months. show original
Hgb ≥ 9g/dL
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: from the start of treatment until 2 years, or until time of death
Screening: ~3 weeks
Treatment: Varies
Reporting: from the start of treatment until 2 years, or until time of death
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: from the start of treatment until 2 years, or until time of death.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether TAS-102 will improve 2 primary outcomes and 5 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Baseline, 1 month post treatment, every 6 months for two years or until death.

Association between KRAS or BRAF mutation status with local control
BASELINE, 1 MONTH POST TREATMENT, EVERY 6 MONTHS FOR TWO YEARS OR UNTIL DEATH
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.
BASELINE, 1 MONTH POST TREATMENT, EVERY 6 MONTHS FOR TWO YEARS OR UNTIL DEATH
The Duration of Local Control
BASELINE, 1 MONTH POST TREATMENT, EVERY 6 MONTHS FOR TWO YEARS OR UNTIL DEATH
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.
BASELINE, 1 MONTH POST TREATMENT, EVERY 6 MONTHS FOR TWO YEARS OR UNTIL DEATH
Toxicity associated with TAS-102 combined with SBRT
FROM START OF TREATMENT UNTIL 4 WEEKS AFTER THE END OF TREATMENT
Summary of the Adverse events experienced during treatment. Adverse events are assessed with Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
FROM START OF TREATMENT UNTIL 4 WEEKS AFTER THE END OF TREATMENT
Maximum Tolerated Dose (MTD)
FROM START OF TREATMENT UNTIL 4 WEEKS AFTER THE END OF TREATMENT
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.
FROM START OF TREATMENT UNTIL 4 WEEKS AFTER THE END OF TREATMENT
Serial ctDNA
BASELINE, WEEK 1, WEEK 2, 1 MONTH POST TREATMENT, AT THE TIME OF PROGRESSION
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
BASELINE, WEEK 1, WEEK 2, 1 MONTH POST TREATMENT, AT THE TIME OF PROGRESSION
Progression Free Survival
FROM THE START OF TREATMENT UNTIL 2 YEARS, OR UNTIL TIME OF PROGRESSION/DEATH
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.
FROM THE START OF TREATMENT UNTIL 2 YEARS, OR UNTIL TIME OF PROGRESSION/DEATH
See More

Who is running the study

Principal Investigator
T. S. H.
Theodore Sunki Hong, Director, Gastrointestinal Service, Department of Radiation Oncology
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of colorectal cancer?

Signs of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) involve loss of stool in stools, black stools of unknown cause, or blood in stools, and may be detectable through examination or through cancer screening. The presence of weight loss in more than 30% of people with colorectal cancer suggests that further investigation is warranted. Although colorectal cancer screening may not solve the problem of cancer, it may decrease the impact of colorectal cancer on deaths, especially for cancers with early signs but less than the maximum life expectancies.

Anonymous Patient Answer

What is colorectal cancer?

In developed countries, colorectal cancer incidence is rising. This may be attributed to increasing use of colonoscopy, increasing age, increased body mass index, and increased consumption of processed white meat (meat dishes and sauces). To reduce the burden of this disease, screening programmes that target the older and overweight population may be effective. Preventive strategies targeting colorectal cancer should take the socioeconomic aspect of the population into consideration.

Anonymous Patient Answer

Can colorectal cancer be cured?

A cure for CRC isn't feasible. A cure implies a cure or a cure: a cure (even if it is possible) doesn't imply cure. That cure is possible for most people with CRC who have been carefully managed according to published clinical guidelines. No one has yet described a cure for CRC with a completely new drug and that cure is only possible for some people. A cure implies a cure for a cure and cure for a cure. A cure with cure means cure. For example, a cure for cure means a cure for cure for cure (treat) a cure for cure.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

Many colorectal cancer patients present for treatment with palliative care, most commonly by chemotherapy, including 5-fluorouracil, irinotecan, oxaliplatine, and oxaliplatin. Colorectal cancer is also often treated with radiation therapy or surgery. Some patients with colorectal cancer are candidates for curative surgery, but in the vast majority, patients are subjected to palliative treatment, such as chemotherapy, radiation therapy, or surgery. Palliative treatment may be provided in an inpatient or outpatient setting. Other treatment is for symptoms, such as bowel obstruction, anal fissures, and blood in the stool.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

Overall, there is variation among states in the incidence of colorectal cancer. Although the absolute risk is 1.1 per 100,000 for blacks and whites, the absolute risk per year for black men and white women is less than 0.7 percent. To reduce the number of cases occurring yearly, the incidence of colorectal cancer should be reduced in blacks and reduced in whites.

Anonymous Patient Answer

What causes colorectal cancer?

Several cancers can cause colorectal cancer; they include [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis), familial adenomatous polyposis and Li-Fraumeni syndrome. Risk factors for colorectal cancer include: a history of chronic colitis or Crohn's disease; being overweight and tobacco use. A history of colorectal cancer and advanced age are associated increased colorectal cancer incidence. An increased risk of colorectal cancer was observed in siblings of those who had colorectal cancer. The risk of colorectal cancer was reduced in first-degree relatives.

Anonymous Patient Answer

What is the average age someone gets colorectal cancer?

It is important to differentiate the average age the cancer is diagnosed from the first symptoms. Symptoms usually occur earlier (about 5-10 years) than a mass or lesion on a colonoscopy and CT scan. Symptoms occur so frequently that an individual may have several lesions or masses that occur over an extended period of time (months to years). Most colorectal cancers are diagnosed after they have become debilitating. Symptoms of colorectal cancer are common in elderly people, with about 1 in 5 diagnosed after they are 80. The average age of diagnosis for colorectal cancer is 70. Many colorectal cancers were diagnosed over the years for individuals who were not currently symptomatic.

Anonymous Patient Answer

Has tas-102 proven to be more effective than a placebo?

• Overall, there were no differences between the 2 treatments at 6 months. • The majority of patients had a very good clinical benefit and were able to stop the therapy. • Tas-102 has proved to be more effective than a placebo in a Phase III study of patients with advanced cancer. • The benefits were measured by the following parameters: time to first progression (TTP), progression-free survival (PFS), overall survival (OS) and tumor-related toxicity. • No significant difference between the 2 treatment groups was found for TTP, OS and tumor-related complications. • TTP was 12.2 weeks less than the placebo treatment (P=0.01) (hazard ratio 0.40) and PFS was 13.

Anonymous Patient Answer

Does tas-102 improve quality of life for those with colorectal cancer?

The use of Tas-102 was safe and associated with improvement in some aspects of HR-QOL. The use of Tas-102 during chemotherapy might be helpful in some patients.

Anonymous Patient Answer

Does colorectal cancer run in families?

There is a familial tendency in CRC, but this tends not be related to the genetic factors known for familial adenomatous polyposis. Because familial polyposis predisposes to other cancers, this might indicate that the genetic predisposition does not trigger CRC but the presence of familial polyposis increases the lifetime probability that CRC will develop.

Anonymous Patient Answer

What are the common side effects of tas-102?

The use of tas-102 is associated with severe, often permanent side effects that need to be considered. These side effects tend to manifest themselves during the first 2 months of therapy. They are related to increased dosages or duration of tas-102 therapy - not due to cumulative exposure or cumulative dose.

Anonymous Patient Answer

Have there been any new discoveries for treating colorectal cancer?

It is clear that we have made a number of improvements in treating colorectal cancer. There are a number of exciting developments relating to colonoscopy and its use in colon cancer detection and the treatment of colorectal cancer. Unfortunately these developments are not available to all of us and the treatment of colorectal cancer has not been simplified to a point where we know the best treatment plan for all patients. However, there is a good possibility that these new methods of treatment will be accepted and the incidence of colorectal cancer will start to fall quickly and, ultimately, colorectal cancer should be treated more easily.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Colorectal Cancer by sharing your contact details with the study coordinator.