Sorafenib +/− Radiation Therapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

+50 other locations

Overseen byLaura Dawson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

Research Team

Laura Dawson

Principal Investigator

Radiation Therapy Oncology Group

Eligibility Criteria

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

I was diagnosed with liver cancer within the last year.

I had surgery before but still meet the study's requirements.

Appropriate for protocol entry based upon minimum diagnostic workup including history/physical examination, assessment by specialists, pre-randomization scans, Zubrod performance status, and blood work with adequate organ marrow function

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Exclusion Criteria

I am HIV positive with a CD4 count below 350.

My cancer has spread directly into nearby organs.

I've had radiation therapy to my liver area before.

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Treatment Details

Interventions

Sorafenib Tosylate (Tyrosine Kinase Inhibitor)
Stereotactic Body Radiation Therapy (Radiation)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: SBRT followed by SorafenibExperimental Treatment2 Interventions

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.

Group II: Sorafenib AloneActive Control1 Intervention

400 mg sorafenib twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.