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

NCT00465023 | Completed DMC

• 1 other identifier: 03-084
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Cancer; Cholangiocarcinoma; Hepatic Metastases

Keywords

proton beam irradiation; liver cancer

Outcome Measures

Primary Outcomes (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.

  4 years

Secondary Outcomes (2)

• To determine safety and tolerance of this treatment program

  4 years

• to evaluate tumor response, local control and survival in this patient population.

Study Arms (1)

Proton Beam Radiation

EXPERIMENTAL

Proton radiation therapy

Procedure: Proton Beam Radiation

Interventions

Proton Beam Radiation PROCEDURE

Once a day, 5 days a week (Monday-Friday) for 3 weeks.

Proton Beam Radiation

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, cholangiocarcinoma, or hepatic metastases.
• Primary lesion size of 6cm or less in greatest diameter
• Single or multinodular tumors (up to 3)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

MeSH Terms

Conditions

Liver Neoplasms; Cholangiocarcinoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Theodore S. Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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: Attending Radiation Oncologist

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: June 1, 2003
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2017
• Last Updated: January 20, 2017

Record last verified: 2017-01