Stereotactic Radiotherapy (SRT) Liver (COLD 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152906
First received: September 8, 2005
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the quality of life. [ Time Frame: assessment: pre-treatement, 1, 3, 6,12 months post ] [ Designated as safety issue: No ]
  • To evaluate changes in liver function following SRT. [ Time Frame: 3 to 12 months ] [ Designated as safety issue: No ]
  • To evaluate patterns of breathing at and during RT. [ Time Frame: during radiation treatment only ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2003
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152906

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

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152906     History of Changes
Other Study ID Numbers: UHN REB 03-0295-C, ASCO Clinical Research Grant
Study First Received: September 8, 2005
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 26, 2014