Overview

This trial is active, not recruiting.

Conditions hepatocellular cancer, cholangiocarcinoma, hepatic metastases
Treatment proton beam radiation
Phase phase 1
Sponsor Massachusetts General Hospital
Collaborator National Cancer Institute (NCI)
Start date June 2003
End date September 2013
Trial size 16 participants
Trial identifier NCT00465023, 03-084

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Proton radiation therapy
proton beam radiation
Once a day, 5 days a week (Monday-Friday) for 3 weeks.

Primary Outcomes

Measure
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 Outcomes

Measure
To determine safety and tolerance of this treatment program
time frame: 4 years
to evaluate tumor response, local control and survival in this patient population.
time frame: TBD

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
Principal investigator Theodore S. Hong, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.