A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.
Princess Margaret Hospital
Toronto, Ontario, Canada
Phase I: To evaluate feasibility and maximally tolerated dose of SRT
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
To evaluate the quality of life.
Time frame: assessment: pre-treatement, 1, 3, 6,12 months post
To evaluate changes in liver function following SRT.
Time frame: 3 to 12 months
To evaluate patterns of breathing at and during RT.
Time frame: during radiation treatment only
To develop more confidence in a revised normal tissue complication probability (NTCP) model for radiation induced liver toxicity and collect preliminary data to determine how the liver responds to radiation.
Time frame: at 3 months post RT
To determine whether serum cytokines and P-III-P can help predict RILD.
Time frame: baseline, during radiation and up to 3 months post radiation
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