## Protocol Section
### Identification Module
**NCT ID:** NCT01815879

**Acronym:** MORE

**Brief Title:** Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project

**Official Title:** Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project

#### Organization Study ID Info
**ID:** MORE
#### Organization
**Class:** INDUSTRY
**Full Name:** Sarah Cannon
### Status Module
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2013-03-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-03-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2013-03

#### Study First Post Date
**Date:** 2013-03-21
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-18
**Study First Submit QC Date:** 2013-03-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Sirtex Medical

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Andrew Kennedy

#### Responsible Party

**Investigator Affiliation:** Sarah Cannon

**Investigator Full Name:** Andrew Kennedy

**Investigator Title:** Principal Investigator and Sponsor-Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Colorectal Cancer

- Liver Metastases

**Keywords:**

- metastatic colorectal cancer

- liver metastases

- 90Y resin microsphere radioembolization

- retrospective data analysis

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Label:** Control Group

### Outcomes Module

#### Primary Outcomes

**Description:** Multiple systems monitored for side effects possibly related to liver radiotherapy.

**Measure:** Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.

Exclusion Criteria:

* Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with colorectal liver metastases in the USA treated with 90Y resin microsphere radioembolization

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nashville

**Country:** United States

**Facility:** Contact Sarah Cannon

**State:** Tennessee

**Zip:** 37203

#### Overall Officials

**Official 1:**

**Affiliation:** SCRI Development Innovations, LLC

**Name:** Andrew S Kennedy, MD, FACRO

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Metastases

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000008113

- Term: Liver Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
