Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy

NCT ID: NCT00972036

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-12-31

Brief Summary

This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.

Conditions

Colon Cancer; Rectal Cancer

Keywords

COLON; LIVER; RECTUM; SIR-Spheres; 09-030

Study Design

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

Study Groups

Unresectable colon cancer patients with liver metastases

This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy.

Group Type: EXPERIMENTAL

SIR-spheres® (Selective Internal Radiation Therapy)

Intervention Type: DEVICE

SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.

Interventions

SIR-spheres® (Selective Internal Radiation Therapy)

SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Histologic confirmation of colorectal cancer.
• Unequivocal imaging of hepatic metastases.
• Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
• Unresectable liver metastases.
• Liver Metastases non-eligible for, or progressed after ablation
• Failed prior HAC.
• ECOG performance status 0 - 1
• WBC > or = to 1.5 x 109/L
• Platelets > or = to 50 x 109/L
• Creatinine ≤ 1.5 mg/dl
• Bilirubin ≤ 1.5 mg/dl
• Age > or = to 18 years
• Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
• Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
• Life expectancy of at least 3 months without any active treatment.
• No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration

Exclusion Criteria

• Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
• Previous radiotherapy delivered to the liver.
• Pregnant or breast-feeding.

• With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
• With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.

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

Sponsors

Sirtex Medical

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constantinos Sofocleous, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

09-030

Identifier Type: -

Identifier Source: org_study_id