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Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria (HCC)

Primary Purpose

Carcinoma, Hepatocellular

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiotherapy
Sorafenib
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients are candidates to receive both proton beam and sorafenib
  2. Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

  1. Patients who are candidates for surgical resection
  2. Patients with tumor burden within Milan and/or San Francisco criteria
  3. Patients who have contraindication to receive proton
  4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
  5. Patients treated previously by any locoregional treatment
  6. Patients with prior liver transplant
  7. Patients with child class C
  8. Patients with model for end-stage liver disease (MELD) score of > 25
  9. Patients with other comorbid diseases that may impact survival
  10. Patients with ongoing alcohol intake
  11. Patients with active sepsis
  12. Patients with gastrointestinal bleeding within a week
  13. Patients unwilling to sign informed consent form
  14. Patients with history of noncompliance

Sites / Locations

  • Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Proton Beam Radiotherapy plus Sorafenib

Sorafenib

Arm Description

A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.

Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.

Outcomes

Primary Outcome Measures

Overall Survival Rate Between Time of Consent and Time of Death
All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2010
Last Updated
September 21, 2021
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT01141478
Brief Title
Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria
Acronym
HCC
Official Title
Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
due to low enrollment
Study Start Date
September 8, 2010 (Actual)
Primary Completion Date
December 26, 2014 (Actual)
Study Completion Date
June 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Beam Radiotherapy plus Sorafenib
Arm Type
Active Comparator
Arm Description
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiotherapy
Intervention Description
Fifteen consecutive sessions
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
400 mg po bid
Primary Outcome Measure Information:
Title
Overall Survival Rate Between Time of Consent and Time of Death
Description
All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.
Time Frame
Change between time of informed consent and primary completion date of study, an average of 4 years per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are candidates to receive both proton beam and sorafenib Patients with tumor burden that exceeds San Francisco criteria Exclusion Criteria: Patients who are candidates for surgical resection Patients with tumor burden within Milan and/or San Francisco criteria Patients who have contraindication to receive proton Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug Patients treated previously by any locoregional treatment Patients with prior liver transplant Patients with child class C Patients with model for end-stage liver disease (MELD) score of > 25 Patients with other comorbid diseases that may impact survival Patients with ongoing alcohol intake Patients with active sepsis Patients with gastrointestinal bleeding within a week Patients unwilling to sign informed consent form Patients with history of noncompliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael deVera, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria

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