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NRG DT001

Trial Overview

Official Title

Testing The Safety Of Combining The Investigational Drug, Amg 232, With Standard Of Care Radiation Therapy Prior To Surgery In Soft Tissue Sarcoma

Study Purpose

To test the safety of a study drug called AMG 232 given with radiation in patients with sarcoma prior to surgery.

Diagnosis

Soft Tissue Sarcoma

Eligibility

Tumor must be at least 5cm.

Planned definitive surgical resection of the primary tumor.

No prior systemic therapy for this cancer.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

All participants will receive AMG 232 (the study drug) and the usual care radiation to the tumor prior to surgery.  Patients will receive the study drug (AMG-232) alone for 1 week and the study drug plus the usual radiation for 5 weeks, for a total of 6 weeks of treatment.

The study will evaluate two groups based on where the tumor is located. 

Group A:  Participants in this group have sarcoma on their extremities (arms/legs) or body wall.  Radiotherapy will be directed to this region as for the usual care.

Group B:  Participants in this group have sarcoma in the abdomen/pelvis or the “retroperitoneum” (a space behind our bowels). Radiotherapy will be directed to this region as for the usual care.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase IB
Methodist Health System Trial Code
DT001
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