NCT00152906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

13 years

First QC Date

September 8, 2005

Last Update Submit

August 13, 2020

Conditions

Liver NeoplasmsNeoplasm Metastases

Outcome Measures

Primary Outcomes (2)

  • Phase I: To evaluate feasibility and maximally tolerated dose of SRT

    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.

    assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years

Secondary Outcomes (6)

  • To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.

    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.

    assessment: pre-treatement, 1, 3, 6,12 months post

  • To evaluate changes in liver function following SRT.

    3 to 12 months

  • To evaluate patterns of breathing at and during RT.

    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.

    at 3 months post RT

  • +1 more secondary outcomes

Study Arms (1)

Stereotactic RT or highly conformal RT

EXPERIMENTAL
Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)

Interventions

Stereotactic radiotherapy (SRT) or highly conformal (CRT)PROCEDURE

SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.

Stereotactic RT or highly conformal RT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23547075DERIVED

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Laura Dawson, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2016

Study Completion

July 10, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

CA(1)