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Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Liver Metastases From Colorectal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Liver Metastasis

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Trial Information

Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Liver Metastases From Colorectal Carcinoma

From July 2003 to May 2007, over 50 patients with liver metastases participated in two
studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating
liver metastases with SBRT. These studies have shown that SBRT can be delivered safely to
the majority of patients with liver metastases. The treated tumour was controlled (shrank or
remained the same size) in 74% of patients at one year following treatment. The median
survival of patients was 16 months (i.e.half of patients survived longer and half shorter
than 16 months). This survival rate is better than that expected in patients whose tumours
grew bigger even though they were treated with chemotherapy. Supportive care only (no
treatment other than care to make you feel better) in these patients is associated with a
median survival rate of 6-12 months. We expect that the benefits of SBRT in this study will
be similar to those observed in our initial studies.

Inclusion Criteria:

- Eligible patients must have liver metastases from colorectal cancer 1) with
histologic confirmation of metastases, 2) histologic confirmation of primary cancer
and multiple new enhancing lesions in the liver consistent with metastases, or 3)
histologic confirmation of primary cancer and a growing enhancing lesion in the liver
Phase II SBRT Mets 13 consistent with a metastases

- Either 1) the tumour must be unresectable, based on the opinion of an experienced
surgeon specializing in hepatic resection, or 2) the patient must be medically
inoperable, or 3) extra-hepatic metastases must be present (making hepatic surgery an
inappropriate treatment option).

- Karnofsky performance status (KPS) > 60 (Appendix II)

- Age: 18 years or older. Both male & female patients of all races can be included in
this study. Female patients within reproductive years may not be, nor become,
pregnant during participation in this study

- Patients must have recovered from the effects of previous therapy

- Maximal tumor size of 15 cm

- Adequate organ function as assessed as follows:

- Hemoglobin > 90 g/L

- Absolute neutrophil count > 1.0 bil/L

- Platelets > 60bil/L

- Bilirubin < 4.0 times upper range of normal

- INR < 1.5 or correctable with vitamin K (unless patients are on anticoagulation doses
that have been stable for the past 2 months and they haven't had a bleed in the past
2 months)

- AST or ALT < 6.0 times upper limit of normal range

- Child's A 5-6 liver score

- Previous liver resection or ablative therapy is permitted

- Life expectancy > 3 months

- The volume of uninvolved must be at least 700 cc

- Up to five discrete liver tumors

- Patients must have signed a study-specific informed consent form. If the patient's
mental status precludes this, written informed consent may be given by the patient's
legal representative.

Exclusion Criteria:

- Patients with active hepatitis or encephalopathy related to liver failure

- Prior radiation therapy to the right upper abdomen, precluding reirradiation of the
liver. That is, any previous radiation therapy in which a mean dose to the liver of
15 Gy in conventional fractionation was delivered, or previous doses to critical
normal structures that would make re-irradiation unsafe. The PI should be called if
there is any question of safety of re-irradiation.

- Prior uncontrolled, life threatening malignancy within the six months.

- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and
acceptable methods of contraception are warranted.

- Previous variceal bleed within the past 2 months

Type of Study:


Study Design:

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

Outcome Measure:

Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Laura Dawson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 07-0348-C



Start Date:

August 2007

Completion Date:

August 2015

Related Keywords:

  • Liver Metastasis
  • Stereotactic Body Radiation Therapy
  • Liver Metastasis from colorectal cancer
  • Patients with Liver Metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms