Study on Radiation Therapy With or Without Chemotherapy or Pazopanib Before Surgery for Treating Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02180867

Provider View

This clinical trial is exploring whether adding the drug pazopanib to radiation therapy, with or without chemotherapy, before surgery can improve treatment outcomes for patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if combining the drug pazopanib with radiation therapy, and possibly chemotherapy, can help treat patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas. Radiation therapy uses high-energy x-rays to kill cancer cells, while chemotherapy drugs like ifosfamide and doxorubicin work to stop cancer cells from growing and spreading. Pazopanib may help by blocking certain enzymes needed for cancer cell growth. Researchers want to see if these treatments work better together and if they can be safely combined.

Description

The main goals of this study are to determine the best dose of pazopanib when used with radiation or chemoradiation and to see if adding pazopanib improves the treatment response in patients with intermediate to high-risk non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). The study will compare how well the cancer responds to treatment with and without pazopanib, looking at factors like tumor shrinkage and survival rates.

The study is divided into different parts:

  • Chemotherapy Cohort: Patients are randomly assigned to receive either:

    • Regimen A: Pazopanib with chemotherapy drugs ifosfamide and doxorubicin, followed by radiation therapy, surgery, and more treatment.
    • Regimen B: Chemotherapy drugs ifosfamide and doxorubicin, followed by radiation therapy, surgery, and more treatment.

  • Non-Chemotherapy Cohort: Patients are randomly assigned to receive either:

    • Regimen C: Pazopanib with radiation therapy, followed by surgery and more treatment.
    • Regimen D: Radiation therapy, followed by surgery and more treatment.

After completing the study treatment, patients will have follow-up visits at regular intervals to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be able to swallow whole tablets and have a body surface area of at least 0.5 m².
  • Newly diagnosed with non-rhabdomyosarcoma soft tissue sarcomas that can potentially be removed by surgery.
  • Cancer located in the extremities or trunk, not in the head, neck, or certain internal organs.
  • Eligible for chemotherapy if the tumor is larger than 5 cm and of a certain grade, and if the cancer type is sensitive to chemotherapy.
  • Eligible for non-chemotherapy if the tumor is of a certain type that is resistant to chemotherapy.
  • Must have adequate blood counts and organ function as determined by specific medical tests.
  • Must not have had prior treatment with certain chemotherapy drugs or radiation to the tumor site.
  • Must be willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Patients with grade 1 tumors or tumors in the central nervous system are not eligible.
  • Patients with uncontrolled high blood pressure or certain heart conditions are not eligible.
  • Patients who have had prior treatment with certain drugs or radiation are not eligible.
  • Patients with other types of cancer that are not disease-free within 3 years are not eligible.
  • Patients who cannot swallow tablets or have a body surface area less than 0.5 m² are not eligible.
  • Pregnant or breastfeeding women are not eligible, and women of childbearing potential must have a negative pregnancy test and agree to use contraception.

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