Comparing TACE alone to TACE with SBRT for liver cancer treatment
A Phase III Randomized Trial of Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Primary or Secondary Liver Carcinoma
This study is testing whether combining a common liver cancer treatment called TACE with a special type of radiation therapy called SBRT works better than TACE alone for patients with liver cancer that can’t be surgically removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT03895359 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transarterial chemoembolization (TACE) alone versus TACE combined with stereotactic body radiation therapy (SBRT) in patients with hepatocellular carcinoma (HCC). TACE is a standard treatment that delivers chemotherapy directly to the liver tumors, while SBRT is a precise radiation therapy that may enhance tumor control. The study aims to determine which treatment approach offers better outcomes for patients with unresectable liver cancer. Participants will be randomly assigned to receive either treatment, and their responses will be monitored over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with unresectable hepatocellular carcinoma and specific measurable liver lesions.
Not a fit: Patients with resectable liver tumors or those with significant extrahepatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with liver cancer, potentially improving survival rates.
How similar studies have performed: Previous studies have shown promising results for TACE in liver cancer treatment, but the combination with SBRT is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary hepatobiliary cancer confirmed pathologically * Non - lymphoma liver metastases confirmed pathologically * Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously negative CT or MRI of the liver * Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis. * ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry. * Primary liver lesion or liver metastases measuring ≤ 25 cm. * Extrahepatic cancer is permitted if liver involvement is judged to be life - limiting. * All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria. * Patient must be judged medically or surgically unresectable * Zubrod Performance Scale = 0 - 3 * Age \> 18 * All intrahepatic disease must be amenable to TACE * Previous liver resection or ablative therapy is permitted. * Chemotherapy must be completed at least 2 weeks prior to radiation therapy or TACE, and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment. * Life expectancy \> 6 months. * Women of childbearing potential and male participants must practice adequate contraception. * Patient must sign study specific informed consent prior to study entry. Pretreatment Evaluations Required for Eligibility: * A complete history and general physical examination. * CBC, INR, Total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry. Appropriate levels are as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells / mm3 * Platelets ≥ 70,000 cells / mm3 * Hemoglobin ≥ 8.0 g / dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g / dl is acceptable.) * Total bilirubin \< 3 mg / dL * Prothrombin time / INR \< 2 (if not on anticoagulants) * Albumin ≥ 28 g / L * AST and ALT \< 10 times ULN Exclusion Criteria: * Severe cirrhosis or liver failure defined as Child Pugh \> B7 * Primary liver tumor or liver metastasis \> 25 cm in maximal dimension. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Severe, active co-morbidity, defined as limiting the patients life to less than 6 months * Active hepatitis or clinically significant liver failure. * Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic.
Where this trial is running
London, Ontario
- London Health Sciences Centre, London Regional Cancer Program — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Lock, M.D. — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study coordinator: Michael Lock, M.D.
- Email: michael.lock@lhsc.on.ca
- Phone: 519-685-8650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.