Stereotactic Radiotherapy (SRT) Liver (COLD 1)

NCT ID: NCT00152906

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2020-07-10

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.

Conditions

Liver Neoplasms; Neoplasm Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic RT or highly conformal RT

Group Type: EXPERIMENTAL

Stereotactic radiotherapy (SRT) or highly conformal (CRT)

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Dawson, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23547075 (View on PubMed)

Other Identifiers

ASCO Clinical Research Grant

Identifier Type: -

Identifier Source: secondary_id

UHN REB 03-0295-C

Identifier Type: -

Identifier Source: org_study_id