Phase 2
N=45
Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00956930 ↗Enrolled (actual)
45
Serious AEs
20.9%
Results posted
Oct 2019
Primary outcome: Primary: Time to Progression (TTP) in Patients Treated With TACE and Y90 — 26; 6.8 Months — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- yttrium Y 90 glass microspheres (Radiation); Doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) in Patients Treated With TACE and Y90 |
26; 6.8 | 0.007 sig |
| SECONDARY Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment |
20; 14; 3; 5 | — |
| SECONDARY Overall Survival |
18.6; 17.7 | — |
Summary
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Hepatocellular Carcinoma confined to the liver that is unresectable with surgery or unable to be treated with radiofrequency ablation diagnosed by biopsy or imaging criteria (CT/MRI)
- No segmental, lobar, or main portal vein thrombosis as evidenced by CT or MRI imaging
Inclusion Criteria
- Adults > 18 years old of either gender
- Diagnosis of liver confined HCC confirmed by histology or American Association for the Study of Liver Diseases (AASLD) guidelines [59,60] [appendix A].
- Lesions 200 and radiological evidence (arterial hypervascularity) of lesion > 2 cm does not require biopsy.
- Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating "arterial hypervascularity" in the background of cirrhosis does not require biopsy
- One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy
- Atypical appearances on imaging requires a biopsy.
- Non-conclusive biopsy requires closer monitoring
- For non-cirrhotics (by biopsy or imaging findings), diagnosis of HCC requires biopsy
- Patients with class II New York Heart Association (NYHA). Patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Patients with infiltrative HCC are not eligible.
- Patients with bulk disease (≥70% tumor replacement of liver) are not eligible.
- Patients with ≥50% tumor replacement of liver, with an albumin Common Toxicity Criteria for Adverse Events (CTCAE v 4.0) Grade 2
- Any condition (psychological, physical or use/abuse of substances) which, in the opinion of the principal investigator (PI) or a sub-investigator (sub-I), would possibly endanger the subject during their participation in the study, or allow for non-compliance with the investigational drug and treatment under study.
- Due to the experimental nature of the therapy and the unknown risk to a fetus, pregnant and/or lactating women are not eligible to participate in this study.
- In the opinion of the investigator, patient is not a candidate/lesion not amenable for RFA (e.g. lesion location, shape, abnormal coagulation parameters, multi-focality).
Data sourced from ClinicalTrials.gov (NCT00956930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.