Overview

This trial is active, not recruiting.

Conditions liver neoplasms, neoplasm metastases
Treatment stereotactic radiotherapy (srt) or highly conformal (crt)
Phase phase 1/phase 2
Sponsor University Health Network, Toronto
Collaborator American Society of Clinical Oncology
Start date July 2003
End date December 2015
Trial size 140 participants
Trial identifier NCT00152906, ASCO Clinical Research Grant, UHN REB 03-0295-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
Principal investigator Laura Dawson, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.