Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities (NCT04037527) | Clinical Trial Compass
TerminatedPhase 1
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
Stopped: Terminated due DLTs
United States9 participantsStarted 2020-08-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.