Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00465023
First received: April 23, 2007
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Cancer Cholangiocarcinoma Hepatic Metastases |
Procedure: Proton Beam Radiation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine safety and tolerance of this treatment program [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- to evaluate tumor response, local control and survival in this patient population. [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | April 2019 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Proton Beam Radiation
Once a day, 5 days a week (Monday-Friday) for 3 weeks.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00465023 History of Changes |
| Other Study ID Numbers: | 03-084 |
| Study First Received: | April 23, 2007 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
proton beam irradiation liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Neoplasm Metastasis Neoplasms, Second Primary Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013