Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Public ClinicalTrials.gov record NCT01168791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
Study identification
- NCT ID
- NCT01168791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 447 participants
Conditions and interventions
Conditions
Interventions
- doxorubicin in combination with palifosfamide-tris Drug
- doxorubicin in combination with placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Feb 28, 2013
- Completion
- Feb 28, 2013
- Last update posted
- Jul 17, 2013
2010 – 2013
United States locations
- U.S. sites
- 73
- U.S. states
- 38
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Arizona Oncology Associates | Phoenix | Arizona | — | — |
| Not listed | Scottsdale | Arizona | — | — |
| Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| University of California, Los Angeles | Los Angeles | California | — | — |
| Not listed | Los Angeles | California | — | — |
| University of California, Irvine | Orange | California | — | — |
| Not listed | Pomona | California | — | — |
| Sarcoma Oncology Center | Santa Monica | California | — | — |
| University of Colorado Cancer Center | Aurora | Colorado | — | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | — | — |
| Medical Oncology Hematology Consultants | Newark | Delaware | — | — |
| MedStar Research Institute | Washington D.C. | District of Columbia | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Moffitt Cancer Center | Tampa | Florida | — | — |
| Palm Beach Cancer Institute | West Palm Beach | Florida | — | — |
| Emory | Atlanta | Georgia | — | — |
| Medical College of Georgia | Augusta | Georgia | — | — |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Park Ridge | Illinois | — | — |
| Indiana University Simon Cancer Center | Indiannapolis | Indiana | — | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | — | — |
| Kansas City Cancer Center | Overland Park | Kansas | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport | Louisiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Mayo Clinic | Rochester | Minnesota | — | — |
| St.Louis University | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Hackensack | New Jersey | — | — |
| Not listed | Morristown | New Jersey | — | — |
| Saint Barnabas | West Orange | New Jersey | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | — | — |
| University of Rochester | Rochester | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| University of North Carolina | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | — | — |
| Summa Health System | Akron | Ohio | — | — |
| UC Cancer Institute | Cinncinnati | Ohio | — | — |
| Cleveland Clinic | Cleveland | Ohio | — | — |
| The Ohio State University Medical Center | Columbus | Ohio | — | — |
| Cancer Care Associates | Tulsa | Oklahoma | — | — |
| Oregon Health and Science University | Portland | Oregon | — | — |
| Not listed | Bethelehem | Pennsylvania | — | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | — | — |
| Pennsylvania Oncology/Hematology Associates | Philadelphia | Pennsylvania | — | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Not listed | Providence | Rhode Island | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Cancer Centers of the Carolinas | Greenville | South Carolina | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Texas Oncology | Bedford | Texas | — | — |
| Texas Oncology - Medical City Dallas | Dallas | Texas | — | — |
| Cancer Therapy and Research Center | San Antonio | Texas | 8229 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | — | — |
| Not listed | Burlington | Vermont | — | — |
| Virginia Cancer Specialists | Fairfax | Virginia | — | — |
| University of Washington/Seattle Cancer Care Alliance | Seattle | Washington | — | — |
| Bellin Cancer Center | Green Bay | Wisconsin | 54313 | — |
| University of Wisconsin | Madison | Wisconsin | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 88 non-U.S. sites.
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- NCT04055753: Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01168791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2013 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01168791 live on ClinicalTrials.gov.