Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
Reason given: Terminated due DLTs
Key facts
- Where
- Winston-Salem, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT04037527
- Record updated
- 6 July 2026
- Original description
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.Read full original descriptionShow less
Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities
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.
Inclusion: 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.
Exclusion: Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives; Patients taking an investigational agent are excluded; Patients who underwent unplanned excision or other previous surgery involving the affected extremity; History of radiation to the limb; Pregnant and nursing women are excluded; Patients who require amputation for local control; Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.