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CompletedNCT00465023Updated Jan 20, 2017

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

An interventional study of Proton Beam Radiation in Hepatocellular Cancer, Cholangiocarcinoma and Hepatic Metastases, sponsored by Massachusetts General Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-20.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Hepatocellular Cancer
  • Cholangiocarcinoma
  • Hepatic Metastases

Keywords

  • proton beam irradiation
  • liver cancer
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 16 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Proton Beam Radiation

    Proton radiation therapy

    Procedure: Proton Beam Radiation

Interventions

  • ProcedureProton Beam Radiation

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

06

What researchers measure

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.

    Time frame: 4 years

Secondary outcomes

  1. To determine safety and tolerance of this treatment program

    Time frame: 4 years

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00465023
Lead sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI), Dana-Farber Cancer Institute, Brigham and Women's Hospital
Responsible party
Theodore Sunki Hong (Attending Radiation Oncologist, Massachusetts General Hospital) — Principal investigator
First posted
Apr 24, 2007
Start date
Jun 2003
Primary completion
Sep 2013
Completion
Jan 2017
Last update
Jan 20, 2017

Study contacts

Theodore S. Hong, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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