Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

NCT03812289 | Terminated Results DMC FDA Device

• 3 other identifiers: STUDY00018810NCI-2018-02864SOL-18142-L
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT

  "Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.

  From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first

Secondary Outcomes (7)

• Localized Control Rate

  From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first

• Incidence of Intrahepatic Progressive Disease

  From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.

• Incidence of Extrahepatic Progressive Disease

  From first dose of SBRT to time of extrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.

• Proportion of Participants That Proceed to Transplantation

  From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.

• Overall Survival

  From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.

Other Outcomes (3)

• Quality of Life (QoL) Scores for European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Questionnaire

  From screening to death or 2 years after last SBRT dose, whichever occurs first.

• QoL Scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire

  From screening to death or 2 years after last SBRT dose, whichever occurs first.

• Proportion With Histopathologic Changes in Irradiated Tumor Sites Relative to Uninvolved Liver Tissue

  At transplantation

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT)

Eligibility Criteria

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution
• Have a Child-Pugh (CP) score \>= B8
• Eastern Clinical Oncology Group (ECOG) performance status =\< 2, or Karnofsky performance scale \> 60
• Must have a life expectancy \> 12 weeks
• Safe radiation treatment planning parameters that adhere to all organs at risk constraints per section 5.1 of the protocol. If normal organs at risk constraints (including at least 700cc of uninvolved liver) are unable to be met at the lowest dose modification (30 Gy in 5 fractions), the patient is deemed ineligible for SBRT and deemed a screen failure
• Except for prior radiotherapy or radioembolization, other prior therapies to previously treated lesions, are permitted
• People of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year without an alternative medical cause
• Note: Abstinence is acceptable if this is the preferred contraception for the participant
• No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years

You may not qualify if:

• Participants have any one of the following liver tumor characteristics:
• Have \> 5 liver tumors, or
• Maximal diameter \> 5 cm
• Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
• Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
• For fiducial marker placement:
• Have a gold allergy
• Any coagulopathy preventing safe fiducial placement
• Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
• Participation in another concurrent treatment protocol
• Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Radiation Oncology Institute: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

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

Results Point of Contact

• Title: Nima Nabavizadeh, MD
• Organization: OHSU Knight Cancer Institute

nabaviza@ohsu.edu

503-418-3685

Study Officials

• Nima Nabavizadeh, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 7, 2019
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Locations

US (1)