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Nucleoside analog

TAS-102 + Radiation for Colorectal Cancer

Phase 1 & 2
Recruiting
Led By Theodore S. Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Extrahepatic disease is allowed if stable for 3 months prior to study entry, with dominant disease burden intrahepatic and referral for definitive radiation therapy to the liver
Child-Pugh classification Group A for patients with underlying cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until 2 years, or until time of death
Awards & highlights

Study Summary

This trial is studying how well TAS-102 and radiation therapy work in treating patients with hepatic metastases from colorectal cancer.

Who is the study for?
Adults with colorectal cancer that has spread to the liver (1-4 metastases) and is inoperable due to location, fitness, or additional disease outside the liver. Participants should have stable extrahepatic disease for 3 months, measurable disease by CT scan, no prior liver radiation but may have had other treatments if more than 3 weeks ago. They must be physically able to take oral medication and not pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing a combination of TAS-102 (Trifluridine), an oral chemotherapy drug, with Photon SBRT (a type of precise radiation therapy). The goal is to assess how well this combo works for treating liver metastases from colorectal cancer compared to current standard treatments.See study design
What are the potential side effects?
TAS-102 can cause fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems. Radiation therapy might result in skin changes at the treatment site, fatigue, and potential damage to nearby organs like the stomach or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer outside the liver is stable, and I'm referred for liver-focused radiation.
Select...
My liver function is mildly affected.
Select...
I have colorectal cancer with 1-4 liver metastases and enough healthy liver tissue.
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My liver cancer cannot be removed due to its location, my health, or because it has spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a tumor that is at least 10 mm large, confirmed by a CT scan.
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My organs and bone marrow are functioning normally.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until 2 years, or until time of death
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment until 2 years, or until time of death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
The Duration of Local Control
Secondary outcome measures
Association between KRAS or BRAF mutation status with local control
Overall Survival
Progression Free Survival
+2 more

Side effects data

From 2019 Phase 3 trial • 507 Patients • NCT02500043
42%
Anaemia
38%
Neutropenia
37%
Nausea
33%
Decreased appetite
26%
Fatigue
24%
Vomiting
22%
Diarrhoea
19%
Asthenia
17%
Leukopenia
15%
Abdominal pain
15%
Neutrophil count decreased
13%
Constipation
10%
Thrombocytopenia
9%
Blood alkaline phosphatase increased
8%
Platelet count decreased
7%
Pyrexia
7%
Abdominal pain upper
7%
White blood cell count decreased
7%
Back pain
6%
Lymphopenia
6%
General physical health deterioration
6%
Weight decreased
6%
Hypoalbuminaemia
6%
Aspartate aminotransferase increased
6%
Dyspnoea
5%
Alanine aminotransferase increased
5%
Oedema peripheral
5%
Blood bilirubin increased
5%
Ascites
4%
Abdominal distension
4%
Dysphagia
4%
Stomatitis
4%
Alopecia
3%
Hypokalaemia
3%
Malaise
3%
Hyperglycaemia
3%
Dysgeusia
3%
Hypocalcaemia
3%
Cough
3%
Hyperbilirubinaemia
3%
Blood creatinine increased
3%
Pleural effusion
3%
Urinary tract infection
3%
Anxiety
3%
Insomnia
2%
Arthralgia
2%
Oral candidiasis
2%
Pancytopenia
2%
Palpitations
2%
Oedema
2%
Hypomagnesaemia
2%
Dizziness
2%
Headache
2%
Blood urea increased
2%
Paraesthesia
2%
Pruritus
2%
Hypotension
2%
Mucosal inflammation
2%
Upper respiratory tract infection
1%
Musculoskeletal pain
1%
Haemorrhoidal haemorrhage
1%
Impaired gastric emptying
1%
Febrile neutropenia
1%
Flatulence
1%
Dyspnoea exertional
1%
Dry skin
1%
Pneumonia aspiration
1%
Productive cough
1%
Pulmonary embolism
1%
Chills
1%
Infection
1%
Septic shock
1%
Tonsillitis
1%
Liver disorder
1%
Tachycardia
1%
Jaundice
1%
Small intestinal obstruction
1%
Obstruction gastric
1%
Acute coronary syndrome
1%
Pneumonia
1%
Pain
1%
Rectal haemorrhage
1%
Herpes zoster
1%
Haemoglobin decreased
1%
Hepatic enzyme increased
1%
Tumour haemorrhage
1%
Shock haemorrhagic
1%
Abdominal discomfort
1%
Dyspepsia
1%
Dry mouth
1%
Gastrooesophageal reflux disease
1%
Abdominal pain lower
1%
Melaena
1%
Nasopharyngitis
1%
Fall
1%
Oesophageal pain
1%
Bronchitis
1%
Protein total decreased
1%
Odynophagia
1%
Conjunctivitis
1%
Toothache
1%
Respiratory tract infection
1%
Hyponatraemia
1%
Lymphocyte count decreased
1%
Dehydration
1%
Groin pain
1%
Choluria
1%
Urinary retention
1%
Cachexia
1%
Pain in extremity
1%
Tumour pain
1%
Somnolence
1%
Dysphonia
1%
Neutropenic sepsis
1%
Haematemesis
1%
Spinal pain
1%
Cancer pain
1%
Pallor
1%
Vertigo
1%
Cystitis
1%
Decubitus ulcer
1%
Dermatitis
1%
Myocardial infarction
1%
Gastric haemorrhage
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Failure to thrive
1%
Enzyme level increased
1%
Gamma-Glutamyltransferase increased
1%
Bone pain
1%
Myalgia
1%
Lethargy
1%
Neuropathy peripheral
1%
Peripheral sensory neuropathy
1%
Epistaxis
1%
Hiccups
1%
Oropharyngeal pain
1%
Nail disorder
1%
Night sweats
1%
Palmar-Plantar erythrodysaesthesia syndrome
1%
Rash
1%
Deep vein thrombosis
1%
Embolism
1%
Hypertension
1%
Metastases to central nervous system
1%
Chest discomfort
1%
Chest pain
1%
Ileus
1%
Intestinal obstruction
1%
Hepatic failure
1%
Lower respiratory tract infection
1%
Rhinitis
1%
Red blood cell count decreased
1%
Muscle atrophy
1%
Agitation
1%
Confusional state
1%
Delirium
1%
Depression
1%
Acute kidney injury
1%
Dysuria
1%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAS-102+BSC
Placebo+BSC

Trial Design

1Treatment groups
Experimental Treatment
Group I: TAS-102Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifluridine
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,367 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,528 Total Patients Enrolled
Theodore S. Hong, MDPrincipal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
719 Total Patients Enrolled

Media Library

TAS-102 (Nucleoside analog) Clinical Trial Eligibility Overview. Trial Name: NCT03223779 — Phase 1 & 2
Colorectal Cancer Research Study Groups: TAS-102
Colorectal Cancer Clinical Trial 2023: TAS-102 Highlights & Side Effects. Trial Name: NCT03223779 — Phase 1 & 2
TAS-102 (Nucleoside analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03223779 — Phase 1 & 2

Frequently Asked Questions

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

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~8 spots leftby Mar 2025