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.
- Malignant Cutaneous Granular Cell Tumor
- Plexiform Fibrohistiocytic Tumor
- Sclerosing Epithelioid Fibrosarcoma
- Undifferentiated High Grade Pleomorphic Sarcoma of Bone
- Liver Embryonal Sarcoma
- Low Grade Fibromyxoid Sarcoma
- Malignant Peripheral Nerve Sheath Tumor
- Extra Skeletal Myxoid Chondrosarcoma
- Fibrohistiocytic Neoplasm
- Alveolar Soft Part Sarcoma
- Angiomatoid Fibrous Histiocytoma
- Atypical Fibroxanthoma
- Clear Cell Sarcoma of Soft Tissue
- Extraskeletal Osteosarcoma
- Inflammatory Myofibroblastic Tumor
- Intimal Sarcoma
- Myxofibrosarcoma
- Myxoid Chondrosarcoma
- Myxoinflammatory Fibroblastic Sarcoma
- Synovial Sarcoma
- Leiomyosarcoma
- Liposarcoma
- Low Grade Myofibroblastic Sarcoma
- Malignant Triton Tumor
- Chondrosarcoma
- PEComas
- Pericytic Neoplasm
- Fibrosarcoma
- Nerve Sheath Tumors
- Skin Glomus Tumor
- Epithelioid Sarcoma
- Stage IIB Soft Tissue Sarcoma
- Stage III Soft Tissue Sarcoma
- Stage IB Soft Tissue Sarcoma
- Stage IV Soft Tissue Sarcoma
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
5 Primary · 4 Secondary · Reporting Duration: From enrollment up to 60 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
4 Treatment Groups
Regimen A (pazopanib, chemoradiation)
1 of 4
Regimen B (chemoradiation)
1 of 4
Regimen C (pazopanib, radiation therapy)
1 of 4
Regimen D (radiation therapy)
1 of 4
Experimental Treatment
140 Total Participants · 4 Treatment Groups
Primary Treatment: Radiation Therapy · No Placebo Group · Phase 2 & 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria | 100.0% |
What state do they live in?
Colorado | 100.0% |
How many prior treatments have patients received?
3+ | 100.0% |
- Weiss, Aaron R, Yen-Lin Chen, Thomas J Scharschmidt, Yueh-Yun Chi, Jing Tian, Jennifer O Black, Jessica L Davis, et al.. 2020. “Pathological Response in Children and Adults with Large Unresected Intermediate-grade or High-grade Soft Tissue Sarcoma Receiving Preoperative Chemoradiotherapy with or Without Pazopanib (ARST1321): A Multicentre, Randomised, Open-label, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30325-9.
- Vatner, Ralph, Charles D. James, Vythialingam Sathiaseelan, Kathryn M. Bondra, John A. Kalapurakal, and Peter J. Houghton. 2020. “Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.28439.
- Avutu, Viswatej, Aaron R. Weiss, Damon R. Reed, Safia K. Ahmed, Wendy A. Allen-Rhoades, Yen-Lin E. Chen, Lara E. Davis, et al.. 2022. “Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321”. Journal of Adolescent and Young Adult Oncology. Mary Ann Liebert Inc. doi:10.1089/jayao.2021.0103.
- Vatner, Ralph, Charles D. James, Vythialingam Sathiaseelan, Kathryn M. Bondra, John A. Kalapurakal, and Peter J. Houghton. 2020. “Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.28439.
- Avutu, Viswatej, Aaron R. Weiss, Damon R. Reed, Safia K. Ahmed, Wendy A. Allen-Rhoades, Yen-Lin E. Chen, Lara E. Davis, et al.. 2022. “Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321”. Journal of Adolescent and Young Adult Oncology. Mary Ann Liebert Inc. doi:10.1089/jayao.2021.0103.
- 2014. "Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02180867.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor