Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization

NCT02762266 | Terminated Phase 3 Results DMC

• 4 other identifiers: IRB-35937NCI-2016-00418P30CA124435HEP0052
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 2

Brief Summary

This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.

Conditions

Child-Pugh Class A; Child-Pugh Class B; Recurrent Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Local Progression Event

  Local progression event: occurring in the treated hepatic lesion.

  Up to 12 months

Secondary Outcomes (11)

• Comparison of Median Freedom From Extra Hepatic Progression

  Up to 16 weeks

• Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group

  At 18 months

• Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group

  At 18 months

• Median OS

  Time from randomization until death from any cause, assessed up to 3 years

• Median OS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group

  At 18 months

Study Arms (2)

Arm I (TACE)

ACTIVE COMPARATOR

Patients undergo TACE.

Procedure: Transarterial Chemoembolization; Drug: embolic agent; Drug: lipiodol

Arm II (SBRT)

EXPERIMENTAL

Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SBRT

Arm II (SBRT)

Transarterial Chemoembolization PROCEDURE

Undergo TACE

Also known as: TACE

Arm I (TACE)

embolic agent DRUG

. Acceptable embolic agents include: * Gelatin sponge (gelfoam) * Polyvinyl alcohol (PVA) particles * Microspheres / Embolic beads

Arm I (TACE)

lipiodol DRUG

Arm I (TACE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed hepatocellular carcinoma (HCC) by one of the following:
• Histopathology
• One radiographic technique that confirms a lesion \>= 1 cm with arterial hypervascularization with washout on delayed phase
• Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE; this evaluation should be within 6 weeks of date of study eligibility
• Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension; multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
• Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2
• Patients with liver disease classified as Child Pugh class A or B, with score =\< 9 ((within 4 weeks of treatment)
• Life expectancy \>= 6 months
• Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document

You may not qualify if:

• Prior radiotherapy to the upper abdomen
• Prior radioembolization to the liver
• Prior radiofrequency ablation (RFA) to index lesion
• Liver transplant
• Active gastrointestinal bleed within 2 weeks of study enrollment
• Ascites refractory to medical therapy (mild to moderate ascites is allowed)
• Women who are pregnant or breastfeeding
• Administration of chemotherapy within the last 1 month
• Extrahepatic metastases
• Participation in another concurrent treatment protocol
• Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery; ethylene-vinyl alcohol copolymer; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Limitations and Caveats

This study did not enroll the planned number of participants and did not meet the protocol-prespecified threshold for statistical significance.

Results Point of Contact

• Title: Erqi Pollom, MD
• Organization: Stanford University

erqiliu@stanford.edu

(650) 498-0484

Study Officials

• Erqi Liu Pollom, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Daniel Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology (Radiation Therapy)

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 4, 2016
• Study Start: February 27, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); US (1)