Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

Stopped early · Phase 1

Conditions studied: Soft Tissue Sarcoma

In brief

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

Key facts

Study ID

NCT04037527

Run by

Wake Forest University Health Sciences

People needed

9

Starts

2020-08-18

Expected to finish

2024-06-18

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation.
• Age greater than or equal to 18 years. No children will be enrolled on this protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives.
• Patients taking an investigational agent are excluded.
• Pregnant and nursing women are excluded.
• Patients who require amputation for local control.
• Patients who underwent unplanned excision or other previous surgery involving the affected extremity.
• Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.
• History of radiation to the limb.

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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