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Anthracyclines

Chemotherapy + Radiation for Soft Tissue Sarcoma

Phase 2 & 3
Waitlist Available
Led By Aaron R Weiss
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified [NOS]")
Patients on low molecular weight heparin or Coumadin with a stable international normalized ratio (INR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment up to 60 months
Awards & highlights

Study Summary

This trial is testing the combination of pazopanib, chemotherapy, and radiation therapy or radiation therapy alone to treat patients with non-rhabdomyosarcoma soft tissue sarcomas.

Who is the study for?
This trial is for patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be surgically removed. Eligible participants include those with various types of sarcoma, adequate organ function, and no metastases to the central nervous system. They must be able to swallow tablets, have a life expectancy of at least 3 months, and not have received certain prior treatments.Check my eligibility
What is being tested?
The study is testing whether pazopanib combined with chemotherapy (ifosfamide and doxorubicin) and radiation therapy works better than radiation alone in treating these sarcomas before surgery. Pazopanib blocks enzymes needed for tumor growth while chemotherapy kills or stops cancer cells from dividing.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, hair loss from chemotherapy; high blood pressure, liver changes from pazopanib; skin irritation from radiation; plus risks associated with surgery such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My sarcoma is not classified under specific types.
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I am on blood thinners with a stable INR.
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My doctor expects me to live at least 3 more months with treatment.
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I don't have shortness of breath at rest, can exercise, and my oxygen level is above 94%.
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My initial cancer cannot be surgically removed, but there's a plan to operate on the main tumor.
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I can provide tissue and blood samples for study.
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My cancer is larger than 5 cm but hasn't spread widely, and is moderately to poorly differentiated.
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I can swallow pills and my body size is suitable for the treatment.
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My type of sarcoma has responded to chemotherapy before.
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My hemoglobin level is at least 8 g/dL if I'm 16 or younger, or at least 9 g/dL if older.
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My bilirubin levels are within normal range for my age.
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My liver enzymes are within normal limits for my age.
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I am over 16 and can care for myself but may not be able to do active work.
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My kidney function is normal or near normal.
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I am 16 or younger and can do most activities without help.
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I have a new, operable soft tissue sarcoma in my limb or trunk.
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My diagnosis was confirmed with a biopsy, not just a fine needle aspiration.
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I am medically considered fit (or unfit) for chemotherapy.
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My cancer has not spread or has spread to other parts of my body.
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My cancer is at a high risk of spreading, needing chemotherapy.
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I can swallow pills and my body surface area is at least 0.5 m^2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasible Dose: Adult
Feasible Dose: Pediatric
Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
+2 more
Secondary outcome measures
Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
Percentage of Patients Local Failure Free at 5 Years Following Study Entry
Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
+1 more
Other outcome measures
Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax)
Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib
Prevalence of Circulating Tumor DNA (ctDNA)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Regimen D (radiation therapy)Experimental Treatment2 Interventions
INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.
Group II: Regimen C (pazopanib, radiation therapy)Experimental Treatment4 Interventions
INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.
Group III: Regimen B (chemoradiation)Experimental Treatment5 Interventions
See Regimen B Detailed Description.
Group IV: Regimen A (pazopanib, chemoradiation)Experimental Treatment7 Interventions
See Regimen A Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Doxorubicin
2012
Completed Phase 3
~7940
Ifosfamide
2010
Completed Phase 4
~2980
Pazopanib
2012
Completed Phase 4
~1370
Pazopanib Hydrochloride
2009
Completed Phase 2
~820
Radiation Therapy
2017
Completed Phase 3
~7250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,506 Total Patients Enrolled
28 Trials studying Liposarcoma
2,003 Patients Enrolled for Liposarcoma
Aaron R WeissPrincipal InvestigatorChildren's Oncology Group

Media Library

Liposarcoma Research Study Groups: Regimen A (pazopanib, chemoradiation), Regimen C (pazopanib, radiation therapy), Regimen B (chemoradiation), Regimen D (radiation therapy)
Liposarcoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02180867 — Phase 2 & 3
Doxorubicin (Anthracyclines) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02180867 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have any previous data to compare the results of this trial to?

"Clinical research for Radiation Therapy began in 1997. The first study was completed that year and was sponsored by Alfacell. After the Phase 3 approval was granted, following the first trial's completion, the number of active trials for this intervention has grown to 1099. They are being conducted across 74 different nations and in 2321 unique cities."

Answered by AI

Are there different research hospitals testing this new treatment in town?

"This clinical trial is being hosted at Stanford Cancer Institute Palo Alto in Palo Alto, California, Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center in Denver, Colorado, and Saint Joseph's Hospital/Children's Hospital-Tampa in Tampa, Florida. 100 other locations are also participating."

Answered by AI

What are the goals that this experiment seeks to achieve?

"The primary outcome of this study is to assess the feasibility of a pediatric dose of the medication. This will be evaluated over a 6-week induction period. Secondary outcomes include the percentage of patients who are local failure-free at 5 years following study entry, the percentage of patients who are regional failure-free at 5 years following study entry, and the percentage of patients who experience Grade 3 or higher toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)."

Answered by AI

What are some of the most popular reasons people choose to go through Radiation Therapy?

"Radiation therapy is often used as a treatment for small cell lung cancer, but it can also ameliorate symptoms for patients with leukemia, myelocytic, acute, multiple sclerosis, lymphoma."

Answered by AI

What does the research say about the effectiveness of Radiation Therapy?

"The first recorded study of radiation therapy was at Spectrum Health Hospital - Butterworth Campus in 1997. As of now, there have been a total of 1799 completed trials. Out of the 1099 ongoing studies, many are based in Palo Alto, California."

Answered by AI

What is the target recruitment number for this research project?

"This specific study is no longer looking for participants, as it was first posted on 7/11/2014 and last updated on 10/18/2022. However, there are presently 2925 other trials involving pecomas and 1099 Radiation Therapy trials that are actively enrolling patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Colorado
How many prior treatments have patients received?
3+
What site did they apply to?
Parkland Memorial Hospital
Recent research and studies
~13 spots leftby Mar 2025