Stereotactic Radiotherapy (SRT) Liver (COLD 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152906
Recruitment Status : Active, not recruiting
First Posted : September 9, 2005
Last Update Posted : September 20, 2017
American Society of Clinical Oncology
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Neoplasm Metastases Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
Study Start Date : July 2003
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Stereotactic RT or highly conformal RT Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)
SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the quality of life. [ Time Frame: assessment: pre-treatement, 1, 3, 6,12 months post ]
  3. To evaluate changes in liver function following SRT. [ Time Frame: 3 to 12 months ]
  4. To evaluate patterns of breathing at and during RT. [ Time Frame: during radiation treatment only ]
  5. 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 ]
  6. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152906

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
American Society of Clinical Oncology
Principal Investigator: Laura Dawson, MD Princess Margaret Hospital, Canada

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Health Network, Toronto Identifier: NCT00152906     History of Changes
Other Study ID Numbers: UHN REB 03-0295-C
ASCO Clinical Research Grant
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases