Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma
Status: Recruiting
Phase: Phase 2
Diagnosis: Liver Cancer
NCT ID: NCT00976898
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-131
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI:
Harvey Mamon, MD, PhD,
Brigham and Women's Hospital
Site-responsible Investigators:
Theodore Hong, MD,
Massachusetts General Hospital
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
Inclusion Criteria:
- Biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic
cholangiocarcinoma.
Patients with a single lesion must be 12cm or less in greatest dimension. For patients
with two lesions, no lesion may be greater than 10cm in greatest dimension. For patients
with three lesions, no lesion may be greater than 6cm in greatest dimension. Patients may
have single or multinodular tumors (up to 3). There must be no evidence of extrahepatic
tumor. Portal vein involvement or thrombosis is allowed.
- Participants must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
20mm or greater with conventional techniques or as 10mm or greater with spiral CT
scan.
- Patients may have had prior chemotherapy, targeted biological therapy, surgery,
transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for
their disease as long as it is greater than 4 weeks from first protocol radiation
treatment (6 weeks for nitrosoureas or mitomycin C). Patients may not have had prior
radiation to the affected area.
- 18 years of age or older
- Expected survival must be greater than three months
- ECOG Performance Status of 0, 1 or 2
- Normal organ and marrow function as outlined in the protocol
- If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group
B patients should be included in this study.
- Patients must be either surgically sterile or post-menopausal. Male and female
patients of child-bearing potential must agree to use adequate contraception prior to
study entry and for the duration of the study participation.
- Individuals with a history of other malignancies are eligible if they have been
disease-free for at least 5 years and are deemed by the investigator to be at low
risk for recurrence of that malignancy. Individuals with the following cancers are
eligible if diagnosed and treated within the past 5 years: cervical cancer in situ,
and basal cell or squamous cell carcinoma of the skin
Exclusion Criteria:
- Women who are pregnant or lactating
- Patients with 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 liver directed radiation treatment
- Patients may have no serious medical illness, which may limit survival to less than 3
months
- Patients may have no serious psychiatric illness/social situations which would limit
compliance with study requirements
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other study agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia.