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A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer Metastatic

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Trial Information

A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy


Inclusion Criteria:



- Colorectal cancer with metastases progressed after first line treatment

Exclusion Criteria:

- Contraindications to TheraSphere or second line chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months

Safety Issue:

No

Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

TS-102

NCT ID:

NCT01483027

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Colorectal Cancer Metastatic
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Northwestern Memorial HospitalChicago, Illinois  60611
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of WashingtonSeattle, Washington  98195
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of LouisvilleLouisville, Kentucky  40202
Washington UniversitySt. Louis, Missouri  63110
Albany Medical CenterAlbany, New York  12208
Karmanos Cancer InstituteDetroit, Michigan  48201
Indiana University School of MedicineIndianapolis, Indiana  46204
Moffitt Cancer Center & Research InstituteTampa, Florida  33612-9497
University of Virginia Health SystemCharlottesville, Virginia  22903
The Johns Hopkins HospitalBaltimore, Maryland  21205
Medical College of Wisconsin, Inc.Milwaukee, Wisconsin  53226
Legacy Meridian Park Medical CenterTualatin, Oregon  97062
Spectrum Health / Advanced Radiology ServicesGrand Rapids, Michigan  49506
Mt Sinai Medical School, Tisch Cancer InstituteNew York, New York  10029-6574