Chemotherapy + Radiation for Soft Tissue Sarcoma

Recruiting in Palo Alto (17 mi)

+415 other locations

Overseen by Aaron R Weiss

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether a new drug called pazopanib, when combined with chemotherapy and radiation, works better for patients with a specific type of soft tissue cancer. Pazopanib helps stop cancer cells from growing, while chemotherapy and radiation kill the cells. The goal is to see if this combination can improve treatment outcomes.

Research Team

Aaron R Weiss

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

My sarcoma is not classified under specific types.

Your heart is pumping normally, with a strong enough squeeze.

I am on blood thinners with a stable INR.

Exclusion Criteria

I do not have any current bleeding or conditions that cause excessive bleeding.

I had surgery to completely remove my tumor before joining ARST1321.

My high blood pressure is not under control.

Treatment Details

Interventions

• Doxorubicin (Anthracyclines)
• Ifosfamide (Alkylating agents)
• Pazopanib (Tyrosine Kinase Inhibitor)
• Radiation Therapy (Radiation)

Trial Overview 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.

Participant Groups

Group I: Regimen D (radiation therapy) Experimental Treatment 2 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 Treatment 4 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 Treatment 5 Interventions

See Regimen B Detailed Description.

Group IV: Regimen A (pazopanib, chemoradiation) Experimental Treatment 7 Interventions

See Regimen A Detailed Description.

Doxorubicin is already approved in Canada, Japan for the following indications:

Approved in Canada as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Approved in Japan as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School