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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465023
• Other study ID #: 03-084
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: January 19, 2017
• Start date: June 2003
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2017
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatic Metastases
• Hepatocellular Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Proton Beam Radiation
Once a day, 5 days a week (Monday-Friday) for 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute, National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine safety and tolerance of this treatment program		4 years
Secondary	to evaluate tumor response, local control and survival in this patient population.		TBD