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

PHASE1RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

August 18, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Gemcitabine

Gemcitabine will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity on a 3+3 escalating dose (100 mg/m² to 300 mg/m²)

DRUG

Docetaxel

Docetaxel will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity (10 mg/m² to 25 mg/m²).

RADIATION

Radiation

Radiation is to be done with standard preop dose of 50 Gy but at lower doses per fraction. Thus 50.4 Gy in 28 FX. Radiation will be given for 5 days (Monday - Friday) every week for approx. 6 weeks.

PROCEDURE

Surgical Resection

Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.

OTHER

Blood draws

Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.

Trial Locations (1)

27157

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT04037527 - Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities | Biotech Hunter | Biotech Hunter