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: January 3, 2014
Last verified: January 2014

September 8, 2005
January 3, 2014
July 2003
December 2014   (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 ] [ 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 ]
  • 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 ] [ 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 ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
December 2014
December 2014   (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.
Both
18 Years and older
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
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
January 2014

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