Sorafenib +/− Radiation Therapy for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of sorafenib tosylate, both alone and with a specialized type of radiation therapy, in treating liver cancer. The researchers aim to determine if the combination of the drug and radiation therapy is more effective at stopping tumor growth than the drug alone. Participants should have liver cancer that cannot be treated with surgery or other standard methods and should not have received specific prior treatments like sorafenib for an extended period. The trial seeks to determine if the combination treatment can better target and shrink liver tumors while minimizing damage to surrounding healthy tissue. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both treatments in this trial have undergone prior safety testing. Sorafenib, a drug approved for other uses, is generally well-tolerated, though some patients have reported side effects such as diarrhea and tiredness.
For stereotactic body radiation therapy (SBRT), studies have demonstrated its safety for liver cancer. One study found it effectively controlled tumors with few serious side effects, though some patients experienced mild fatigue.
Overall, both sorafenib and SBRT have shown a history of safety in previous studies, providing a strong basis for their use in treating liver cancer in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine Sorafenib, a targeted cancer drug, with or without radiation therapy, offering a potentially more effective approach to liver cancer treatment. Sorafenib works by blocking tumor cell growth and blood vessel formation, a different mechanism compared to traditional chemotherapy, which generally attacks all rapidly dividing cells. The experimental arm includes stereotactic body radiation therapy (SBRT) before Sorafenib, which may enhance the drug's effectiveness by precisely targeting and shrinking tumors before drug treatment. This combination could offer better outcomes for patients than existing treatments alone, like chemotherapy or Sorafenib solo.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research has shown that sorafenib tosylate, which participants in this trial may receive, can inhibit liver cancer growth by blocking certain enzymes essential for cancer cell proliferation. Another treatment option in this trial is stereotactic body radiation therapy (SBRT). Studies have found SBRT to be highly effective for liver cancer patients, particularly those ineligible for surgery. SBRT has successfully controlled liver cancer for up to 5 years, achieving a 95% success rate without severe side effects. This trial will test the combination of SBRT followed by sorafenib to determine if it enhances the ability to kill cancer cells. Together, these treatments aim to provide a more robust approach to managing liver cancer.16789
Who Is on the Research Team?
Laura Dawson
Principal Investigator
Radiation Therapy Oncology Group
Are You a Good Fit for This Trial?
This trial is for patients with liver cancer who have not responded to certain previous treatments and do not have severe other illnesses. They should have at least one tumor in the liver or blood vessel involvement, adequate organ function, no recent serious heart issues, and agree to use contraception. Those with a history of certain treatments like sorafenib over 60 days ago or specific radiotherapies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive stereotactic body radiation therapy (SBRT) in 5 fractions over 5-15 days
Treatment
Participants receive sorafenib tosylate, starting with 200 mg twice a day, increasing to 400 mg twice a day if tolerable, for 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sorafenib Tosylate
- Stereotactic Body Radiation Therapy
Trial Overview
The study is testing if adding stereotactic body radiation therapy (SBRT) to sorafenib treatment provides better outcomes than sorafenib alone for liver cancer patients. SBRT targets tumors precisely with high-dose radiation while sparing healthy tissue. The trial randomly assigns participants to either combined treatment or just the drug.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
400 mg sorafenib twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radiation Therapy Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
NRG Oncology
Collaborator
Published Research Related to This Trial
Citations
Stereotactic body radiotherapy with CyberKnife for liver ...
The incidence of radiation-induced liver disease was 4.3%–15.3%. Stereotactic body radiotherapy using CK appears to be an effective and well- ...
Long term outcomes of Stereotactic Body Radiation Therapy ...
SBRT confers high local control and long-term survival in a substantial proportion of HCC patients unsuitable for, or refractory to standard local/regional ...
Stereotactic Body Radiation Therapy for Hepatocellular ...
This systematic review and meta-analysis reports on outcomes and hepatic toxicity rates after stereotactic body radiation therapy (SBRT) for ...
Long-term outcomes of more than a decade treating ...
SBRT resulted in a 5-year LC of 95% in the treatment of primary liver cancer (HCC). •. No SBRT related ≥ grade 3 toxicity was reported. •. Treatment outcomes of ...
Clinical outcomes and prognostic factors of cyberknife ...
Cyberknife SBRT appears to be an effective non-invasive treatment for local unresectable HCC with low risk of severe toxicity.
Stereotactic body radiation therapy in primary liver tumor
To assess its efficacy and safety, we reviewed all patients treated by SBRT for a hepatocellular carcinoma (HCC) over a six-year period. Methods and materials.
Final Results of a Multicenter Prospective Study ...
A multicenter prospective study of stereotactic body radiation therapy for previously untreated solitary primary hepatocellular carcinoma.
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%.
Imaging Features in the Liver after Stereotactic Body ...
A phase 2 multicenter study of stereotactic body radiotherapy for hepatocellular carcinoma: safety and efficacy. Cancer 2020;126(2):363–372.
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