Stereotactic Body Radiation Therapy (SBRT) in Liver Metastasis (COLD 3)

NCT00914615 | Completed Phase 2 DMC

• 1 other identifier: UHN REB 07-0348-C
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. Presently, the treatment for unresectable liver metastases from colorectal cancer is most often chemotherapy or novel targeted therapy. These treatments may improve survival, but not control the metastases permanently; so new treatments are needed to control metastases. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

Conditions

Liver Metastasis

Keywords

Stereotactic Body Radiation Therapy; Liver Metastasis from colorectal cancer; Patients with Liver Metastasis

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (5)

• Overall progression free survival

  5 years

• Overall survival

  5 years

• Quality of life

  5 years

• CTC3.0 toxicity

  5 years

• Cytokine response to radiation and association with complications

  5 years

Study Arms (1)

SBRT for liver mets from colorectal cancer

EXPERIMENTAL

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation RADIATION

Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver (up to an hour including all imaging and set-up procedures). You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment. Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.

SBRT for liver mets from colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laura Dawson, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: August 1, 2007
• Primary Completion: August 16, 2019
• Study Completion: August 7, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

CA (1)