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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received post-R0 resection of stages II, III, or IV colorectal cancer and has completed all planned adjuvant therapies
Has ECOG performance status (PS) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will measure the level of ctDNA in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy.
Who is the study for?
Adults over 18 with colorectal cancer who've had surgery and finished adjuvant therapy can join. They must have no visible cancer but a positive ctDNA test for minimal residual disease, good organ function, and an ECOG performance status of 0 or 1. Pregnant women, those with severe health issues, allergies to trial drugs, or conditions affecting drug absorption cannot participate.Check my eligibility
What is being tested?
The trial is testing TAS-102's effectiveness in patients with colorectal cancer who show no signs of the disease after treatment but have a positive ctDNA test indicating minimal residual disease. The study monitors ctDNA levels after six months on TAS-102.See study design
What are the potential side effects?
While specific side effects for this trial are not listed, common ones from TAS-102 may include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove colorectal cancer and finished all follow-up treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My scans showed no cancer signs within 28 days of a positive blood test for cancer.
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My colorectal cancer diagnosis was confirmed through tissue examination.
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My blood counts and liver/kidney functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
Side effects data
From 2019 Phase 3 trial • 507 Patients • NCT0250004342%
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%
Abdominal pain upper
7%
White blood cell count decreased
7%
Pyrexia
7%
Back pain
6%
Dyspnoea
6%
Hypoalbuminaemia
6%
Weight decreased
6%
Lymphopenia
6%
General physical health deterioration
6%
Aspartate aminotransferase increased
5%
Blood bilirubin increased
5%
Oedema peripheral
5%
Alanine aminotransferase increased
5%
Ascites
4%
Stomatitis
4%
Dysphagia
4%
Abdominal distension
4%
Alopecia
3%
Hypokalaemia
3%
Dysgeusia
3%
Cough
3%
Malaise
3%
Hyperglycaemia
3%
Hypocalcaemia
3%
Hyperbilirubinaemia
3%
Blood creatinine increased
3%
Pleural effusion
3%
Urinary tract infection
3%
Anxiety
3%
Insomnia
2%
Oedema
2%
Hypomagnesaemia
2%
Dizziness
2%
Arthralgia
2%
Headache
2%
Oral candidiasis
2%
Pancytopenia
2%
Palpitations
2%
Blood urea increased
2%
Paraesthesia
2%
Pruritus
2%
Hypotension
2%
Mucosal inflammation
2%
Upper respiratory tract infection
1%
Urinary retention
1%
Oesophageal pain
1%
Hyponatraemia
1%
Somnolence
1%
Impaired gastric emptying
1%
Dry skin
1%
Chills
1%
Tumour pain
1%
Dysphonia
1%
Jaundice
1%
Pneumonia
1%
Musculoskeletal pain
1%
Septic shock
1%
Fall
1%
Haemoglobin decreased
1%
Pain in extremity
1%
Dyspnoea exertional
1%
Flatulence
1%
Productive cough
1%
Small intestinal obstruction
1%
Pulmonary embolism
1%
Obstruction gastric
1%
Odynophagia
1%
Rectal haemorrhage
1%
Pain
1%
Respiratory tract infection
1%
Epistaxis
1%
Tumour haemorrhage
1%
Protein total decreased
1%
Dehydration
1%
Abdominal discomfort
1%
Nasopharyngitis
1%
Dyspepsia
1%
Dry mouth
1%
Choluria
1%
Liver disorder
1%
Tonsillitis
1%
Haemorrhoidal haemorrhage
1%
Melaena
1%
Toothache
1%
Acute coronary syndrome
1%
Tachycardia
1%
Bronchitis
1%
Infection
1%
Febrile neutropenia
1%
Shock haemorrhagic
1%
Abdominal pain lower
1%
Gastrooesophageal reflux disease
1%
Herpes zoster
1%
Groin pain
1%
Conjunctivitis
1%
Lymphocyte count decreased
1%
Hepatic enzyme increased
1%
Cachexia
1%
Pneumonia aspiration
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%
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 Treatment1 Intervention
TAS-102 should be taken by mouth 2 times a day, within 1 hour after your morning and evening meals (about 12 hours apart).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-102
2019
Completed Phase 3
~2170
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,331 Total Patients Enrolled
TaihoUNKNOWN
Arvind Dasari, MDStudy ChairM.D. Anderson Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many human subjects are included in this experiment?
"Yes, the latest information from clinicaltrials.gov suggests that this study is actively recruiting patients. This trial was first posted on June 6th, 2020 and last updated a day later. They are currently looking for 15 individuals across 1 site."
Answered by AI
Does TAS-102 present any immediate dangers to people?
"TAS-102 safety is graded as a 2 by our team because, while there is evidence of its safety, Phase 2 trials have yet to establish efficacy."
Answered by AI
Are there any slots still available for participants in this research?
"This study is currently looking for candidates. The trial was first posted on 6/6/2022 and was last edited on 6/7/2022."
Answered by AI
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