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Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Liver Neoplasms, Neoplasm Metastases

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Trial Information

Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma

Inclusion Criteria:

- Primary hepatobiliary confirmed pathologically or via imaging

- Liver metastases from colorectal cancer or other solid malignancy, confirmed

- 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 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To evaluate feasibility and maximally tolerated dose of SRT

Principal Investigator

Laura Dawson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Ethics Review Committee

Study ID:

UHN REB 03-0295-C



Start Date:

July 2003

Completion Date:

Related Keywords:

  • Liver Neoplasms
  • Neoplasm Metastases
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis