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

• Sponsor: Loma Linda University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01141478
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 69.1
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Radiation: Proton Beam Radiotherapy; Drug: Sorafenib	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
• Actual Study Start Date: Sep 8, 2010
• Actual Primary Completion Date: Dec 26, 2014
• Actual Study Completion Date: Jun 10, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Proton Beam Radiotherapy plus Sorafenib 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; Fifteen consecutive sessions; Drug: Sorafenib; 400 mg po bid
Active Comparator: Sorafenib Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.	Drug: Sorafenib; 400 mg po bid

Outcome Measures

Primary Outcome Measures

1. Overall Survival Rate Between Time of Consent and Time of Death [Change between time of informed consent and primary completion date of study, an average of 4 years per participant]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Michael deVera, MD, Loma Linda University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT01141478
• Other Study ID Numbers: 5100104
• First Posted: Jun 10, 2010
• Last Update Posted: Oct 15, 2021
• Last Verified: Sep 1, 2021

• 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
• Keywords provided by Loma Linda University: Carcinoma, Hepatocellular; Proton Beam Radiotherapy; Sorafenib
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Sorafenib

Study Results

Participant Flow

Arm/Group Title	Proton Beam Radiotherapy Plus Sorafenib	Sorafenib
Arm/Group 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. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
Period Title: Overall Study
STARTED	4	4
COMPLETED	3	3
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Proton Beam Radiotherapy Plus Sorafenib	Sorafenib	Total
Arm/Group 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. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid	Total of all reporting groups
Overall Participants	4	4	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	4 100%	7 87.5%
>=65 years	1 25%	0 0%	1 12.5%
Sex: Female, Male (Count of Participants)
Female	1 25%	0 0%	1 12.5%
Male	3 75%	4 100%	7 87.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 25%	0 0%	1 12.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	3 75%	3 75%	6 75%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 25%	1 12.5%
Region of Enrollment (participants) [Number]
United States	4 100%	4 100%	8 100%
Alfa-feto protein (ng/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/ml]	1413.8 (1777)	44319 (29640.2)	22866.4 (30082.1)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

two subjects withdrew prior to over all survival rate measurement

Arm/Group Title	Proton Beam Radiotherapy Plus Sorafenib	Sorafenib
Arm/Group 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. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
Measure Participants	3	3
Mean (Full Range) [years]	1.6	0.36

Adverse Events

Time Frame	Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up
Adverse Event Reporting Description	All subjects are at risk for serious and non serious adverse events due to the progression of their liver disease and the possible side effects from both study treatment arms.
Arm/Group Title	Proton Beam Radiotherapy Plus Sorafenib		Sorafenib
Arm/Group 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. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid		Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
All Cause Mortality
	Proton Beam Radiotherapy Plus Sorafenib		Sorafenib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/4 (75%)		3/4 (75%)
Serious Adverse Events
	Proton Beam Radiotherapy Plus Sorafenib		Sorafenib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		0/4 (0%)
General disorders
Death - cerebral hemorrahic stroke	1/4 (25%)	1	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	Proton Beam Radiotherapy Plus Sorafenib		Sorafenib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.