Radiation Therapy for Liver Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests radiation therapy to determine the optimal dose for treating liver cancer, particularly when the liver is already compromised. It targets individuals with specific types of liver cancer or cancer that has metastasized to the liver, who also have liver issues from conditions like cirrhosis or previous treatments. Suitable candidates include those with liver cancer, possibly damaged from past treatments or liver surgery, who still retain a sufficient amount of healthy liver tissue. The trial aims to evaluate the therapy's effectiveness and potential side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you may be allowed to continue taking capecitabine or sorafenib during the trial, as decided by your doctor.

What prior data suggests that this radiation therapy is safe for liver cancer patients?

Past studies have shown that radiation therapy for liver cancer results in a relatively low rate of serious side effects. Research on intensity-modulated radiation therapy (IMRT) found it offers a similar survival rate to other radiation methods but with fewer severe side effects. Another study on stereotactic body radiation therapy (SBRT) showed it is generally safe and well-tolerated, even by patients with liver damage from conditions like cirrhosis. While all treatments can have side effects, these findings suggest that radiation therapy is a promising option for liver cancer with manageable risks.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver cancer, which often include surgery, chemotherapy, and radiofrequency ablation, this radiation therapy approach is unique because it offers a targeted, non-invasive option. Researchers are excited about this treatment because it administers radiation directly to the cancer site over a concise period of 15 or 25 fractions, potentially minimizing damage to surrounding healthy tissue. This precise targeting could lead to fewer side effects and improve the quality of life for patients, making it a promising alternative to more aggressive therapies.

What evidence suggests that radiation therapy might be an effective treatment for liver cancer?

Research has shown that radiation therapy is a promising treatment for liver cancer. In this trial, participants will undergo radiation therapy, which may include techniques such as stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT). Studies indicate that SBRT can control liver cancer in up to 90% of patients, and long-term evidence confirms its effectiveness in managing tumors with few serious side effects. IMRT also proves to be an effective treatment for liver cancer. These findings suggest that radiation therapy can successfully target and shrink liver tumors, offering hope to those with liver cancer.12567

Who Is on the Research Team?

Eugene J. Koay | MD Anderson Cancer Center

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with liver cancer, bile duct cancer, or tumors that have spread to the liver and also have impaired liver function. Participants must have at least 400 ml of functional liver tissue and an ECOG performance status of 0-2. Women who can bear children should use contraception and not breastfeed. Those with recent heart issues, active hepatitis, infections, inflammatory bowel disease or another active malignancy are excluded.

Inclusion Criteria

Signed study-specific consent form
I had liver radiation therapy over 6 months ago for Y90 or over 12 months for others.
I have one or more tumors.
See 11 more

Exclusion Criteria

I currently have a fever or an untreated infection.
I do not have active hepatitis.
My inflammatory bowel disease is not well-managed.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity

3-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Follow-up at 4-8 weeks, then every 3-4 months for 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Radiation Therapy
Trial Overview The study is testing different doses of radiation therapy to find the safest and most effective dose for patients with specific types of liver cancers and compromised liver function. It includes biomarker analysis, MRI scans, surveys on health status, alongside the radiation treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy)Experimental Treatment4 Interventions

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Radiation Therapy for:
🇺🇸
Approved in United States as Radiation Therapy for:
🇨🇦
Approved in Canada as Radiation Therapy for:
🇯🇵
Approved in Japan as Radiation Therapy for:
🇨🇳
Approved in China as Radiation Therapy for:
🇨🇭
Approved in Switzerland as Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.
However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy.Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]
In a study of 260 men with localized prostate cancer treated with high-dose IGRT and IMRT, the combination resulted in a low rate of late toxicity, with only 4.4% experiencing grade 2 gastrointestinal issues and 7.1% with grade 2 genitourinary issues after 7 years.
The treatment showed high efficacy, with a 7-year prostate-specific antigen relapse-free survival rate of 97.1% for low-risk patients, indicating that this approach is both safe and effective for managing prostate cancer.
Long-Term Clinical Results of IGRT in Prostate Cancer Treatment.Doležel, M., Odrážka, K., Vaňásek, J., et al.[2021]
Radiation therapy, including techniques like brachytherapy and stereotactic body radiotherapy (SBRT), is safe and effective for treating liver cancers, with response rates ranging from 50% to 97% in recent studies.
Technological advancements in imaging and radiation delivery have improved the ability to treat difficult-to-reach tumors while minimizing damage to surrounding healthy tissue, making these therapies increasingly viable for patients with compromised liver function.
Radiation oncology approaches in liver malignancies.Kennedy, AS.[2018]

Citations

Stereotactic Body Radiotherapy for Hepatocellular ...Stereotactic body radiotherapy (SBRT), a type of external beam radiotherapy, yields local control of hepatocellular carcinoma (HCC) at rates as high as 90%.
Long-term outcomes of more than a decade treating ...SBRT resulted in excellent long-term local control rates and absence of severe toxicity in a group of HCC patients.
A Systematic Review and Meta-Analysis - PMCIntensity-modulated radiotherapy (IMRT), an advanced RT technique, is a considerable treatment option for hepatocellular carcinoma (HCC).
Final Results of a Multicenter Prospective Study ...A multicenter prospective study of stereotactic body radiation therapy for previously untreated solitary primary hepatocellular carcinoma.
Current perspectives on radiotherapy in hepatocellular ...The pooled grade ≥3 complication rates were 2.9% for RFA and 2.8% for SBRT. The meta-analysis further revealed that SBRT can be more effective ...
Stereotactic body radiation therapy in primary liver tumorSBRT provides good LC with an acceptable safety profile. It can be used in several settings such as salvage therapy or in combination with validated treatment.
Outcomes After Stereotactic Body Radiation for ...Our findings suggest that SBRT is feasible and effective in patients with both CP A and CP B/C liver dysfunction with similar rates of local control and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security