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NCT02180867 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Epithelioid Sarcoma and Alveolar Soft Part Sarcoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
140
Enrollment target
20
Study locations

NCT02180867: Active Phase 2 study of Epithelioid Sarcoma and Alveolar Soft Part Sarcoma, sponsored by National Cancer Institute (NCI).

NCT02180867 is a Phase 2 study of Epithelioid Sarcoma and Alveolar Soft Part Sarcoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 140 participants, above the 84-participant average among 6 other Epithelioid Sarcoma trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02180867, a Phase 2 study of Epithelioid Sarcoma and Alveolar Soft Part Sarcoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
140 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.

Primary Outcome

The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated ad

Interventions

  • DRUG Doxorubicin
  • DRUG Doxorubicin Hydrochloride
  • DRUG Ifosfamide
  • DRUG Pazopanib
  • DRUG Pazopanib Hydrochloride

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

California

  • Kaiser Permanente-Anaheim - Anaheim
  • AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Kaiser Permanente Downey Medical Center - Downey
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Medical Center - Loma Linda

Alabama

  • Children's Hospital of Alabama - Birmingham
  • University of Alabama at Birmingham Cancer Center - Birmingham
  • The Kirklin Clinic at Acton Road - Birmingham

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix
  • Banner University Medical Center - Tucson - Tucson

Arkansas

  • Arkansas Children's Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2014-07-11
Est. Completion 2026-12-24
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02180867 still lists

NCT02180867 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 6 other Epithelioid Sarcoma trials with a reported enrollment target (67% higher).

The record links to 10 conditions, with Epithelioid Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.

NCT02180867 names 20 study sites across 5 states, led by Alaska, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT02180867 about?

NCT02180867 is a clinical study titled "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". This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation thera...

What is the current status of trial NCT02180867?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2014-07-11. Estimated completion is 2026-12-24.

What conditions does trial NCT02180867 study?

This clinical trial studies the following conditions: Epithelioid Sarcoma, Alveolar Soft Part Sarcoma, Fibrosarcoma, Atypical Fibroxanthoma, Angiomatoid Fibrous Histiocytoma.

What interventions are being tested in trial NCT02180867?

The interventions under investigation include: Doxorubicin (DRUG), Doxorubicin Hydrochloride (DRUG), Ifosfamide (DRUG), Pazopanib (DRUG), Pazopanib Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT02180867?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02180867 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02180867, the US trial registry maintained by the National Library of Medicine. NCT02180867 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.