Comparing TACE alone to TACE with SBRT for liver cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.