Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma

NCT00976898 | Completed Results DMC

• 2 other identifiers: 09-131P01CA021239
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 4

Brief Summary

In this study the investigators will be studying the effects of proton beam radiation therapy. This is a very accurate kind of treatment that has been shown to affect less normal tissue than a photon radiation beam. The accuracy allows the investigators to more safely increase the amount of radiation delivered to eliminate cancer. This accuracy will potentially reduce side effects that participants would normally experience using photon radiation therapy. The purpose of this study is to determine if radiation using proton beam therapy will kill the cancer cells in the participants liver.

Conditions

Liver Cancer

Keywords

proton beam radiation

Outcome Measures

Primary Outcomes (2)

• 2 Year Local Control Rate

  The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s).

  2 years

• Median Overall Survival

  The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up.

  5 years

Secondary Outcomes (2)

• Number of Participants With Treatment Related Adverse Events ≥ Grade 3

  2 years

• Patterns of Failure

  2 years

Study Arms (1)

Proton Beam Irradiation

EXPERIMENTAL

This is a single arm study. All study participants will receive proton radiation therapy.

Radiation: Proton Beam Irradiation

Interventions

Proton Beam Irradiation RADIATION

Given once a day, 5 days a week, for 3 weeks

Proton Beam Irradiation

Eligibility Criteria

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

You may qualify if:

• Biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic cholangiocarcinoma. Patients with a single lesion must be 12cm or less in greatest dimension. For patients with two lesions, no lesion may be greater than 10cm in greatest dimension. For patients with three lesions, no lesion may be greater than 6cm in greatest dimension. Patients may have single or multinodular tumors (up to 3). There must be no evidence of extrahepatic tumor. Portal vein involvement or thrombosis is allowed.
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan.
• Patients may have had prior chemotherapy, targeted biological therapy, surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as it is greater than 4 weeks from first protocol radiation treatment (6 weeks for nitrosoureas or mitomycin C). Patients may not have had prior radiation to the affected area.
• years of age or older
• Expected survival must be greater than three months
• ECOG Performance Status of 0, 1 or 2
• Normal organ and marrow function as outlined in the protocol
• If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group B patients should be included in this study.
• Patients must be either surgically sterile or post-menopausal. Male and female patients of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the study participation.
• Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

You may not qualify if:

• Women who are pregnant or lactating
• Patients with evidence of non-hepatic metastatic disease
• Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
• Prior liver directed radiation treatment
• Patients may have no serious medical illness, which may limit survival to less than 3 months
• Patients may have no serious psychiatric illness/social situations which would limit compliance with study requirements
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other study agents
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: collaborator
• University of Pennsylvania: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Pennsylvania, Roberts Proton Facility

Philadelphia, Pennsylvania, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Theodore Sunki Hong, MD
• Organization: Massachusetts General Hospital

tshong1@mgh.harvard.edu

617-724-1159

Study Officials

• Hannah J. Roberts, MD

  Massachusetts General Hospital

  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: September 11, 2009
• First Posted: September 15, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 15, 2025
• Results First Posted: January 31, 2018

Record last verified: 2025-09

Locations

US (4)