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

NCT01141478 | Terminated Results FDA Device

• 1 other identifier: 5100104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular; Proton Beam Radiotherapy; Sorafenib

Outcome Measures

Primary Outcomes (1)

• 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.

  Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Study Arms (2)

Proton Beam Radiotherapy plus Sorafenib

ACTIVE COMPARATOR

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.

Radiation: Proton Beam Radiotherapy; Drug: Sorafenib

Sorafenib

ACTIVE COMPARATOR

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

Drug: Sorafenib

Interventions

Proton Beam Radiotherapy RADIATION

Fifteen consecutive sessions

Proton Beam Radiotherapy plus Sorafenib

Sorafenib DRUG

400 mg po bid

Proton Beam Radiotherapy plus Sorafenib; Sorafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Diane Scavone, research coordinator
• Organization: Loma Linda University Medical Center

dscavone@llu.edu

909 558-3636

Study Officials

• Michael deVera, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 10, 2010
• Study Start: September 8, 2010
• Primary Completion: December 26, 2014
• Study Completion: June 10, 2016
• Last Updated: October 15, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-09

Locations

US (1)