CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Epirubicin Hydrochloride +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02050919
NCT02050919Phase 2Completed

A Phase II Study of Sorafenib With Chemotherapy, Radiation, and Surgery for High-Risk Soft Tissue Sarcomas

OHSU Knight Cancer Institute·interventional·Posted Jan 31, 2014·Updated Mar 21, 2022

In Brief

A Phase 2 clinical trial evaluating Epirubicin Hydrochloride, External Beam Radiation Therapy, and 4 other interventions for Pleomorphic Rhabdomyosarcoma and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride and ifosfamide, 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. Radiation therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue sarcoma.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 31, 2014
Enrollment StartDec 3, 2013
Primary CompletionMay 7, 2018
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.4 years ago

Interventions

Epirubicin Hydrochloridedrug

Given IV

External Beam Radiation Therapyradiation

Undergo EBRT

Ifosfamidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Sorafenib Tosylatedrug

Given PO

Therapeutic Conventional Surgeryprocedure

Undergo surgical resection