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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

Must not have

Women who are pregnant or lactating

Participants with gross ascites or encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment until 2 years, or until time of death

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

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.

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.

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.

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My liver function is mildly affected.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have severe abdominal swelling or brain function issues.

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I have health issues that could make radiation treatment harder for me.

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I have had radiation treatment targeted at my liver.

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I have previously taken the medication TAS-102.

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I am not on any other cancer treatments or experimental drugs.

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I do not have a serious illness that could limit my survival to less than 3 months.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of treatment until 2 years, or until time of death

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

The Duration of Local Control

Secondary study objectives

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%

Neutrophil count decreased

15%

Abdominal pain

13%

Constipation

10%

Thrombocytopenia

Blood alkaline phosphatase increased

Platelet count decreased

Abdominal pain upper

Pyrexia

White blood cell count decreased

Back pain

Aspartate aminotransferase increased

Lymphopenia

Weight decreased

Dyspnoea

General physical health deterioration

Hypoalbuminaemia

Oedema peripheral

Blood bilirubin increased

Alanine aminotransferase increased

Ascites

Abdominal distension

Dysphagia

Stomatitis

Alopecia

Hypokalaemia

Malaise

Dysgeusia

Cough

Hyperglycaemia

Hypocalcaemia

Hyperbilirubinaemia

Blood creatinine increased

Pleural effusion

Urinary tract infection

Anxiety

Insomnia

Oral candidiasis

Oedema

Arthralgia

Dizziness

Headache

Pancytopenia

Palpitations

Hypomagnesaemia

Blood urea increased

Paraesthesia

Pruritus

Hypotension

Mucosal inflammation

Upper respiratory tract infection

Tumour haemorrhage

Pulmonary embolism

Conjunctivitis

Herpes zoster

Pneumonia

Tonsillitis

Somnolence

Pain

Bronchitis

Fall

Productive cough

Abdominal pain lower

Spinal pain

Oesophageal pain

Protein total decreased

Shock haemorrhagic

Flatulence

Melaena

Enzyme level increased

Cancer pain

Dry skin

Groin pain

Gastrooesophageal reflux disease

Dysphonia

Abdominal discomfort

Tumour pain

Dyspnoea exertional

Odynophagia

Nasopharyngitis

Obstruction gastric

Infection

Septic shock

Jaundice

Acute coronary syndrome

Small intestinal obstruction

Febrile neutropenia

Tachycardia

Dry mouth

Dyspepsia

Haemorrhoidal haemorrhage

Impaired gastric emptying

Rectal haemorrhage

Toothache

Chills

Liver disorder

Respiratory tract infection

Haemoglobin decreased

Hepatic enzyme increased

Lymphocyte count decreased

Cachexia

Dehydration

Hyponatraemia

Musculoskeletal pain

Pain in extremity

Choluria

Urinary retention

Epistaxis

Hiccups

Pneumonia aspiration

Neutropenic sepsis

Haematemesis

Pallor

Vertigo

Cystitis

Decubitus ulcer

Dermatitis

Myocardial infarction

Gastric haemorrhage

Gastrointestinal haemorrhage

Upper gastrointestinal haemorrhage

Failure to thrive

Gamma-Glutamyltransferase increased

Bone pain

Myalgia

Lethargy

Neuropathy peripheral

Peripheral sensory neuropathy

Oropharyngeal pain

Nail disorder

Night sweats

Palmar-Plantar erythrodysaesthesia syndrome

Rash

Deep vein thrombosis

Embolism

Hypertension

Metastases to central nervous system

Chest discomfort

Chest pain

Ileus

Intestinal obstruction

Hepatic failure

Lower respiratory tract infection

Rhinitis

Red blood cell count decreased

Muscle atrophy

Agitation

Confusional state

Delirium

Depression

Acute kidney injury

Dysuria

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

TAS-102+BSC

Placebo+BSC

Awards & Highlights

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.

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

0 / 16Eligibility criteria met