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Stereotactic Radiotherapy (SRT) Liver (COLD 1)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152906
First Posted: September 9, 2005
Last Update Posted: September 20, 2017
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.
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
University Health Network, Toronto
September 8, 2005
September 9, 2005
September 20, 2017
July 2003
July 2018   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • Phase I: To evaluate feasibility and maximally tolerated dose of SRT
  • Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
Complete list of historical versions of study NCT00152906 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the quality of life. [ Time Frame: assessment: pre-treatement, 1, 3, 6,12 months post ]
  • To evaluate changes in liver function following SRT. [ Time Frame: 3 to 12 months ]
  • To evaluate patterns of breathing at and during RT. [ Time Frame: during radiation treatment only ]
  • 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 ]
  • 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 ]
  • To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.
  • To evaluate the quality of life.
  • To evaluate changes in liver function following SRT.
  • To evaluate patterns of breathing at and during RT.
  • 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.
  • To determine whether serum cytokines and P-III-P can help predict RILD.
Not Provided
Not Provided
 
Stereotactic Radiotherapy (SRT) Liver (COLD 1)
Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Neoplasms
  • Neoplasm Metastases
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.
Experimental: Stereotactic RT or highly conformal RT
Intervention: Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)
Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
July 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00152906
UHN REB 03-0295-C
ASCO Clinical Research Grant
Not Provided
Not Provided
Not Provided
University Health Network, Toronto
University Health Network, Toronto
American Society of Clinical Oncology
Principal Investigator: Laura Dawson, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP