Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases

• ClinicalTrials.gov Identifier: NCT00465023
• Recruitment Status: Completed
• First Posted: April 24, 2007
• Last Update Posted: January 20, 2017
• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); Dana-Farber Cancer Institute; Brigham and Women's Hospital
• Information provided by (Responsible Party): Theodore Sunki Hong, Massachusetts General Hospital

Study Description

Brief Summary:

The main purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. We will also gather information to determine the ability of proton beam to destroy cancer cells in the liver. There are two types of external radiation treatments (proton beam and photon beam). Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam. The accuracy allows us to more safely increase the amount of radiation delivered to eliminate cancer and may potentially reduce the side effects normally experienced with standard radiation therapy.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Cancer; Cholangiocarcinoma; Hepatic Metastases	Procedure: Proton Beam Radiation	Not Applicable

Detailed Description:

• Participants will receive treatment as an outpatient at the Northeast Proton Treatment Center located at the Massachusetts General Hospital.
• Since we are looking for the highest dose of proton beam radiation that can be given to people safely, not everyone who participates in this study will be receiving the same amount of radiation. Small groups of people will be enrolled and given a certain dose of radiation. If they tolerate it well, the next small group of people enrolled will receive a higher dose. This will continue until we find the highest dose that can be given without causing serious or unmanageable side effects.
• Radiation treatment to the liver will be given once a day, 5 days a week (Monday-Friday), for 3 weeks. Each treatment takes about 10-20 minutes.
• A physical examination, medical history, and blood tests will be taken once a week for 3 weeks during radiation therapy. Follow-up visits will occur every 3 months for 2 years, and every 6 months thereafter for 3 years, and then annually thereafter.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
• Study Start Date: June 2003
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: January 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Proton Beam Radiation; Proton radiation therapy	Procedure: Proton Beam Radiation; Once a day, 5 days a week (Monday-Friday) for 3 weeks.

Outcome Measures

Primary Outcome Measures :

1. To determine the maximum tolerated dose (MTD) of proton beam irradiation in patients with unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases. [ Time Frame: 4 years ]

Secondary Outcome Measures :

1. To determine safety and tolerance of this treatment program [ Time Frame: 4 years ]
2. to evaluate tumor response, local control and survival in this patient population.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Biopsy proven unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases.
• Primary lesion size of 6cm or less in greatest diameter
• Single or multinodular tumors (up to 3)
• 18 years of age or older
• No evidence of extrahepatic tumor
• Karnofsky performance status of 70-100
• If patient has underlying cirrhosis, only Child's classification Group A or Group B
• Adequate renal function
• Expected survival of greater than three months

Exclusion Criteria:

• Pregnant or lactating women
• 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 radiation treatment to affected region
• Serious psychiatric illness which would limit compliance with treatment

Contacts and Locations

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

• Principal Investigator: Theodore S. Hong, MD; Massachusetts General Hospital

More Information

• Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00465023
• Other Study ID Numbers: 03-084
• First Posted: April 24, 2007
• Last Update Posted: January 20, 2017
• Last Verified: January 2017

Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:

proton beam irradiation; liver cancer

Additional relevant MeSH terms:

Neoplasm Metastasis; Cholangiocarcinoma; Liver Neoplasms; Carcinoma, Hepatocellular; Neoplastic Processes; Neoplasms; Pathologic Processes; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases