Breast Cancer, Cholangiocarcinoma, Colorectal Neoplasms, Melanoma, Neuroendocrine Tumors
Conditions
Keywords
Liver metastases
Brief summary
This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
Interventions
DEVICESelective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery
Sponsors
Nicholas Fidelman, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. * The cancer is unresectable. * All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Age 18 years or older. * Able to understand informed consent.
Exclusion criteria
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: * single TheraSphere administration; or * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. * Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition. * Previous radiation therapy to the lungs and/or to the upper abdomen * Pregnancy * Symptomatic lung disease. * Significant extrahepatic disease representing an imminent life-threatening outcome. * Active uncontrolled infection * Any pre-treatment laboratory findings within 30 days of treatment demonstrating: * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. * Serum bilirubin greater than 2 mg/dl * Infiltrative tumor on imaging * Tumor volume greater than 70% of liver volume * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 6 months | Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Response | 6 months after treatment | Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions. |
Participant flow
Recruitment details
Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.
Participants by arm
| Arm | Count |
|---|---|
| Yttrium-90 Radioembolization Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere) | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Yttrium-90 Radioembolization |
|---|---|
| Age, Continuous | 61 years |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 42 |
| serious Total, serious adverse events | 3 / 42 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Yttrium-90 Radioembolization | Number of Participants With Adverse Events | 42 participants |
Secondary
Radiographic Response
Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
Time frame: 6 months after treatment
Population: Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yttrium-90 Radioembolization | Radiographic Response | Complete Response (CR) | 0 participants |
| Yttrium-90 Radioembolization | Radiographic Response | Partial Response (PR) | 4 participants |
| Yttrium-90 Radioembolization | Radiographic Response | Stable Disease (SD) | 12 participants |
| Yttrium-90 Radioembolization | Radiographic Response | Progressive Disease (PD) | 4 participants |
| Neuroendocrine - Yttrium-90 Radioembolization | Radiographic Response | Progressive Disease (PD) | 0 participants |
| Neuroendocrine - Yttrium-90 Radioembolization | Radiographic Response | Stable Disease (SD) | 4 participants |
| Neuroendocrine - Yttrium-90 Radioembolization | Radiographic Response | Complete Response (CR) | 0 participants |
| Neuroendocrine - Yttrium-90 Radioembolization | Radiographic Response | Partial Response (PR) | 7 participants |
| Other Tumors - Yttrium-90 Radioembolization | Radiographic Response | Progressive Disease (PD) | 3 participants |
| Other Tumors - Yttrium-90 Radioembolization | Radiographic Response | Partial Response (PR) | 1 participants |
| Other Tumors - Yttrium-90 Radioembolization | Radiographic Response | Stable Disease (SD) | 6 participants |
| Other Tumors - Yttrium-90 Radioembolization | Radiographic Response | Complete Response (CR) | 0 participants |