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

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.

Conditions

Soft Tissue Sarcoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Soft Tissue Sarcoma
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Shailaja Raj, MRCP, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-09