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| Name | Class |
|---|---|
| Sirtex Medical | INDUSTRY |
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Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:
Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Retrospective review of clinical data on at least 1,000 evaluable US patients with 12+weeks follow up that were treated with 90Y resin microsphere radioembolization for metastatic colorectal liver metastases |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria. | Multiple systems monitored for side effects possibly related to liver radiotherapy. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans. | Pretreatment planning scans (-45 to -1 day) compared to post radiotherapy scans of the liver, PET/CT not recommended, prefer MRI with Gd or CT with contrast, 3 phase, with rescanning in similar fashion at day 90 post treatment. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with colorectal liver metastases in the USA treated with 90Y resin microsphere radioembolization
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S Kennedy, MD, FACRO | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Sarah Cannon | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |