Status:
TERMINATED
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Primary Objective: • To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of ...
Eligibility Criteria
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.
- 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.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04037527
Start Date
August 18 2020
End Date
June 18 2024
Last Update
December 17 2025
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157