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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Cancer, Cholangiocarcinoma, Hepatic Metastases

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Theodore S. Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

03-084

NCT ID:

NCT00465023

Start Date:

June 2003

Completion Date:

April 2019

Related Keywords:

  • Hepatocellular Cancer
  • Cholangiocarcinoma
  • Hepatic Metastases
  • proton beam irradiation
  • liver cancer
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Cholangiocarcinoma

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