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Radiation
Palliative Radiotherapy for Liver Cancer
N/A
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding a single dose of radiation to the liver can help reduce pain and discomfort from cancer, compared to receiving standard care alone.
Who is the study for?
This trial is for adults with advanced liver cancer (hepatocellular carcinoma or colorectal cancer metastases) who experience moderate to severe pain from their tumors. They must have a life expectancy of more than 3 months, be able to follow the study protocol and complete questionnaires in certain languages. Pregnant women or those planning pregnancy are excluded, as well as patients with specific blood work values and those who've had recent chemotherapy, targeted therapy, or radiotherapy.
What is being tested?
The study tests if one dose of palliative radiation therapy aimed at the liver plus standard Best Supportive Care (BSC) can better manage liver-related pain compared to BSC alone in patients with symptomatic hepatocellular carcinoma and liver metastases.
What are the potential side effects?
Potential side effects may include typical reactions associated with radiation therapy such as fatigue, skin changes over the treated area, nausea, vomiting, abdominal pain, and potential worsening of liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort
Secondary study objectives
Proportion of Patients Alive at Day 90.
Side effects data
From 2013 Phase 3 trial • 663 Patients • NCT0010280433%
Fatigue
28%
Anorexia
23%
Nausea
22%
Cough
22%
Dyspnoea
15%
Anaemia
14%
Alanine aminotransferase increased
14%
Rash
13%
Constipation
13%
Vomiting
13%
Pyrexia
12%
Diarrhoea
12%
Aspartate aminotransferase increased
12%
Headache
11%
Asthenia
10%
Chest pain
9%
Back pain
8%
Dizziness
6%
Leukopenia
6%
Oedema peripheral
6%
Paraesthesia
6%
Insomnia
5%
Conjunctivitis
5%
Neutropenia
5%
Lacrimation increased
5%
Pain
5%
Blood creatinine increased
5%
Peripheral sensory neuropathy
5%
Haemoptysis
5%
Alopecia
4%
Stomatitis
4%
Thrombocytopenia
4%
Abdominal pain
4%
Creatinine renal clearance decreased
4%
Haemoglobin decreased
4%
Weight decreased
4%
Hyperglycaemia
4%
Pruritus
3%
Oedema
3%
Dyspepsia
3%
Mucosal inflammation
3%
Bronchitis
3%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Blood alkaline phosphatase increased
3%
Neutrophil count decreased
3%
Arthralgia
3%
Bone pain
3%
Musculoskeletal pain
3%
Myalgia
3%
Pain in extremity
3%
Cancer pain
3%
Productive cough
3%
Hyperhidrosis
3%
Hypertension
2%
Skin hyperpigmentation
2%
Pneumonia
2%
Vision blurred
2%
Abdominal pain upper
2%
Dry mouth
2%
Chills
2%
General physical health deterioration
2%
Influenza like illness
2%
Influenza
2%
Blood lactate dehydrogenase increased
2%
Dehydration
2%
Hyponatraemia
2%
Musculoskeletal chest pain
2%
Dysgeusia
2%
Neuropathy peripheral
2%
Depression
2%
Vaginal haemorrhage
2%
Hiccups
2%
Pharyngolaryngeal pain
2%
Flushing
1%
Respiratory failure
1%
Febrile neutropenia
1%
Urinary tract infection
1%
Lymphadenopathy
1%
Lymphopenia
1%
Tachycardia
1%
Tinnitus
1%
Eyelid oedema
1%
Keratoconjunctivitis sicca
1%
Ocular surface disease
1%
Abdominal distension
1%
Dysphagia
1%
Flatulence
1%
Gastritis
1%
Mouth ulceration
1%
Odynophagia
1%
Toothache
1%
Chest discomfort
1%
Face oedema
1%
Injection site reaction
1%
Localised oedema
1%
Hypersensitivity
1%
Herpes zoster
1%
Infection
1%
Lung infection
1%
Oral candidiasis
1%
Sinusitis
1%
Contusion
1%
Blood creatinine decreased
1%
Gamma-glutamyltransferase increased
1%
Glomerular filtration rate decreased
1%
Neutrophil count increased
1%
Platelet count decreased
1%
Weight increased
1%
White blood cell count decreased
1%
Diabetes mellitus
1%
Hypercalcaemia
1%
Hyperkalaemia
1%
Hypokalaemia
1%
Muscle spasms
1%
Muscular weakness
1%
Neck pain
1%
Tumour pain
1%
Ataxia
1%
Convulsion
1%
Hypoaesthesia
1%
Neuralgia
1%
Tremor
1%
Anxiety
1%
Confusional state
1%
Depressed mood
1%
Dysuria
1%
Pollakiuria
1%
Renal failure
1%
Urinary retention
1%
Epistaxis
1%
Hypoxia
1%
Postnasal drip
1%
Rhinitis allergic
1%
Rhinorrhoea
1%
Wheezing
1%
Dry skin
1%
Pigmentation disorder
1%
Rash pruritic
1%
Hypotension
1%
Superior vena caval occlusion
1%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pemetrexed and BSC
Placebo and BSC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Best Supportive Care + RT 8 Gy/1Experimental Treatment2 Interventions
Patients will be randomized 1:1 to receive best supportive care plus radiation therapy (8 Gy in 1 fraction),
Group II: Best Supportive CareActive Control1 Intervention
Patients will be randomized 1:1 to receive best supportive care alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative Radiation Therapy
2015
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
131 Previous Clinical Trials
69,481 Total Patients Enrolled
Laura Ann DawsonStudy ChairUniv. Health Network-Princess Margaret Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had stable moderate or severe pain for up to a week.I experience severe pain due to liver cancer, rating it 7-10 in the worst cases.I have had radiotherapy to my upper abdomen that affected more than half of my liver.I have not had chemotherapy or TACE in the last 4 weeks.My liver cancer is widespread, has many tumors, or is very large.Standard cancer treatments are not suitable or effective for me.My colorectal cancer has spread and cannot be removed by surgery or treated with intense radiation.My liver cancer diagnosis was confirmed by specific CT or MRI scans.I am using or willing to use effective birth control or am not of childbearing potential.My liver cancer diagnosis was confirmed through lab tests.My most significant cancer area in the liver matches the painful spot, confirmed by a recent scan.I can attend all treatments and follow-ups for the study.I can start the treatment within 5 days of being chosen for the trial.My pain level is 4 or higher and has been stable recently.My doctor expects me to live more than 3 months.My pain level has been moderate or severe but stable recently.I can care for myself but may not be able to do heavy physical work.I experience moderate pain due to liver cancer, rating it 4-6 out of 10.My liver function score is C10 or less.My scans show cancer in the bile ducts, detected less than 4 months ago.I have not taken targeted cancer drugs like Sorafenib in the last 2 weeks.My cancer diagnosis was confirmed through tissue or cell testing.I am 18 years old or older.I am willing to fill out pain questionnaires in English, French, or another validated language.I haven't had a severe infection needing IV antibiotics in the last 28 days.I can and will complete quality of life surveys in English, French, or another available language.I have had liver-targeted radiotherapy before.I am scheduled for chemotherapy, targeted therapy, or TACE soon.My doctor thinks standard treatments won't work for me or have stopped working.My liver cancer cannot be treated with surgery, RFA, TACE, or high-dose radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Best Supportive Care
- Group 2: Best Supportive Care + RT 8 Gy/1
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.
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