Stereotactic Radiotherapy (SRT) Liver - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto American Society of Clinical Oncology
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152906

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer Radiation Therapy

U.S. FDA Resources

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

Primary Outcome Measures:

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.

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.
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.

Estimated Enrollment:	140
Study Start Date:	July 2003

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

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

Contacts

Contact: Laura Dawson, MD

416-946-2125

laura.dawson@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Laura Dawson, MD 416-946-2125 laura.dawson@rmp.uhn.on.ca
Principal Investigator: Laura Dawson, MD

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

Study ID Numbers:	UHN REB 03-0295-C, ASCO Clinical Research Grant
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00152906 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms

Neoplasm Metastasis
Gastrointestinal Neoplasms
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Neoplastic Processes
Liver Diseases
Neoplasms
Pathologic Processes

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasm Metastasis

ClinicalTrials.gov processed this record on August 30, 2009