Stereotactic Radiotherapy (SRT) Liver (COLD 1)

University Health Network, Toronto

Status and phase

Completed

Phase 2

Phase 1

Conditions

Liver Neoplasms

Neoplasm Metastases

Treatments

Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT00152906

ASCO Clinical Research Grant

UHN REB 03-0295-C

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary hepatobiliary confirmed pathologically or via imaging
Liver metastases from colorectal cancer or other solid malignancy, confirmed pathologically
New radiographic liver lesions most consistent with metastases, in a patient with previously pathologically proven solid malignancy and a previously negative liver contrast CT or MRI
The tumor must be unresectable or the patient must be medically inoperable or extra-hepatic metastases must be present
Karnofsky performance status (KPS) > 60
Age > 18 years
Patients must have recovered from the effects of previous surgery, radiotherapy or chemotherapy
Chemotherapy must be completed at least 2 weeks prior to radiation therapy or not planned to be administered for at least 2 weeks
Adequate organ function as assessed as follows:Hemoglobin > 90 g/L, Absolute neutrophil count > 1.5 bil/L, Platelets > 80,000 bil/L, Bilirubin < 3.0 times upper range of normal, INR < 1.3 or correctable with vitamin K, AST or ALT < 6.0 times upper range of normal, Creatinine < 200 umol/L (other than patients who are having dialysis or already have dialysis lines in place for future dialysis for renal failure. These patients may be treated on study with no upper limit on their creatinine.)
Child A liver score
Previous liver resection or ablative therapy is permitted.
Life expectancy > 3 months
Multiple metastases are permitted (volume of uninvolved must be at least 800 cc, and the maximal effective liver volume that may be treated is 80%.
Informed consent form

Exclusion criteria

Patients with active hepatitis or clinically significant liver failure
Prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver. (Prior pelvic radiation is permitted, as long as no overlap between pelvic and liver radiation fields occurs.)
Prior uncontrolled, life threatening malignancy within the past year.
Gross (clinically apparent) ascites.
Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and birth control are warranted.