Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
Phase III Randomized Trial of Gadolinium Texaphyrin (PCI-0120) Injection as a Radiation Sensitizer in Patients Receiving Whole Brain Radiation Therapy for the Treatment of Brain Metastases
5 other identifiers
interventional
430
2 countries
35
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with radiation therapy is more effective than radiation therapy alone in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 1998
Longer than P75 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2001
CompletedFirst Posted
Study publicly available on registry
April 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedOctober 31, 2013
June 1, 2008
3.1 years
November 1, 1999
October 29, 2013
Conditions
Keywords
Study Arms (2)
WBRT
EXPERIMENTAL3 Gy of WBRT daily for a total of 10 days
MGd
EXPERIMENTALIV does of 5.0 mg/kg MGd plus WBRT
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (35)
Marin Oncology Associates, Inc.
Greenbrae, California, 94904, United States
Kaiser Permanente Medical Group
Los Angeles, California, 90027, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010, United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816, United States
University of Colorado Cancer Center
Denver, Colorado, 80262, United States
Charlotte County Radiation Therapy Regional Center
Port Charlotte, Florida, 33952, United States
Emory Clinic
Atlanta, Georgia, 30365, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265, United States
Hematology and Oncology Services - Metairie
Metairie, Louisiana, 70006, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Harper Hospital and Wayne State University
Detroit, Michigan, 48201, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417, United States
North Memorial Research Center
Minneapolis, Minnesota, 55442-2900, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
New Mexico Oncology-Hematology
Albuquerque, New Mexico, 87102, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Abington Hematology Oncology Associates
Meadowbrook, Pennsylvania, 18974, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, 15213, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Related Publications (2)
Li J, Bentzen SM, Li J, Renschler M, Mehta MP. Relationship between neurocognitive function and quality of life after whole-brain radiotherapy in patients with brain metastasis. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):64-70. doi: 10.1016/j.ijrobp.2007.09.059.
PMID: 18406884RESULTLi J, Bentzen SM, Renschler M, Mehta MP. Regression after whole-brain radiation therapy for brain metastases correlates with survival and improved neurocognitive function. J Clin Oncol. 2007 Apr 1;25(10):1260-6. doi: 10.1200/JCO.2006.09.2536.
PMID: 17401015RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Markus Renschler, MD
Pharmacyclics LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
April 30, 2004
Study Start
August 1, 1998
Primary Completion
September 1, 2001
Study Completion
June 1, 2005
Last Updated
October 31, 2013
Record last verified: 2008-06