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TAS-102 + Radiation for Colorectal Cancer
Study Summary
This trial is studying how well TAS-102 and radiation therapy work in treating patients with hepatic metastases from colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 507 Patients • NCT02500043Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding.I have severe abdominal swelling or brain function issues.I have health issues that could make radiation treatment harder for me.I have had radiation treatment targeted at my liver.I have previously taken the medication TAS-102.My cancer outside the liver is stable, and I'm referred for liver-focused radiation.I agree to use birth control during the study.I can take pills by mouth.My liver function is mildly affected.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I am not on any other cancer treatments or experimental drugs.I do not have a serious illness that could limit my survival to less than 3 months.I have colorectal cancer with 1-4 liver metastases and enough healthy liver tissue.My liver cancer cannot be removed due to its location, my health, or because it has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have a tumor that is at least 10 mm large, confirmed by a CT scan.I had treatments like chemotherapy or surgery for my condition over 3 weeks ago.I do not have any uncontrolled illnesses.My organs and bone marrow are functioning normally.I am 18 years old or older.
- Group 1: TAS-102
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many test subjects are included in this experiment?
"That is correct. Presently, this clinical trial is seeking 56 participants from 1 site. The study was initially posted on 10/13/2017 and was most recently edited on 9/7/2022, according to data found on clinicaltrials.gov"
Why was this research project undertaken?
"The sponsor of this study, Taiho Oncology, Inc., is measuring the Maximum Tolerated Dose (MTD) as the primary outcome over a Baseline, 1 month post treatment, every 6 months for two years or until death time span. Additionally, this trial will assess secondary outcomes including Serial ctDNA and Progression Free Survival. Local control is also being measured with respect to KRAS or BRAF mutation status."
Is this the first time TAS-102 has been studied?
"As of right now, 44 different clinical trials are running that focus on TAS-102. Of these active studies, 5 have progressed to Phase 3 testing. Even though the majority of TAS-102 research is conducted in Lakewood, New jersey, there are a total of 654 medical centres across the globe conducting trial for this medication."
Is this research the first to be conducted on this topic?
"TAS-102 is being trialed in 44 different ongoing studies spread out over 33 countries and 248 cities. The first trial for this drug was completed in 2017 and involved 56 patients. So far, 27 trials have been completed."
What type of cancer has TAS-102 shown the most success in treating?
"TAS-102 is most frequently used to treat vaccinia infection in the cornea and conjunctiva. However, it can also be prescribed for other conditions, such as blepharitis and previous oxaliplatin chemotherapy or anti-vegf treatment."
Are patients currently being recruited for this research study?
"That's right. If you check the listing on clinicaltrials.gov, you'll see that this research is looking for participants. The trial was first posted on 10/13/2017 and was updated as recently as 9/7/2022. So far, 56 people have been recruited from 1 site."
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