Neoplasms

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Liver Extracts

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

Proton Beam Radiation

Theodore S. Hong, MD

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.

* 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.

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

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

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Attending Radiation Oncologist

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

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

Proton Beam Irradiation

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.

* Participants will receive treatment as an outpatient in the Francis H. Burr Proton Center at the Massachusetts General Hospital, the MD Anderson Proton Therapy Center or the Roberts Proton Therapy Center at the University of Pennsylvania.
* Not everyone who participates in this study will be receiving the same dose of radiation. The dose received will be determined by the location of the tumor(s) within the liver.
* Proton Beam radiation therapy to the liver will be given once a day, 5 days a week (Monday-Friday), for 2 weeks.
* The following procedures will be performed once a week during treatment on days 1, 8 and 15, as well as on the last day of radiation: physical examination and blood tests.

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

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

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).

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.

Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3).

A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up

M.D. Anderson Cancer Center

University of Pennsylvania

Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.

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

Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks

Age, Continuous

Sex: Female, Male

White

Black

Asian

Hispanic (white or black)

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Hepatitis C Virus (HCV) (± Others)

No HCV but Hepatitis B Virus (HBV) (± Others)

No HCV/HBV but Ethyl Hepatocellularalcohol (EtOH)

No HCV/HBV/EtOH but nonalcoholic steatohepatitis

Other

None

Underlying Liver Disease

Eastern Cooperative Oncology Group (ECOG) score:

* 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
* 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
* 2 - Symptomatic, \<50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)

ECOG Performance Status

No Cirrhosis

Child-Turcotte-Pugh Class is used to evaluate the prognosis of chronic liver disease (primarily cirrhosis). Classes are determined using 5 clinical measures of liver disease with 1 to 3 points given for each measure, with more points given for less favorable clinical criteria. The 5 measures are total bilirubin, serum albumin, prothrombin time/international normalized ratio (INR), Ascites, and hepatic encephalopathy grade. The classes are A (5-6 points), B (7-9 points), and C (10-15 points) with 'A' having the best survival outcomes and C having the worst.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases	NCT00465023	Hepatocellular ... Cholangiocarcin... Hepatic Metasta...	Proton Beam Rad...	18 Years -	Massachusetts General Hospital
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases	NCT00465023	Hepatocellular ... Cholangiocarcin... Hepatic Metasta...	Proton Beam Rad...	18 Years -	Massachusetts General Hospital
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma	NCT00976898	Liver Cancer	Proton Beam Irr...	18 Years -	Massachusetts General Hospital
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases	NCT00465023	Hepatocellular ... Cholangiocarcin... Hepatic Metasta...	Proton Beam Rad...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for proton beam irradiation