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

Last updated: March 19, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Soft Tissue Sarcoma

Sarcoma

Sarcoma (Pediatric)

Treatment

Blood draws

Docetaxel

Gemcitabine

Clinical Study ID

NCT04037527
IRB00061621
CCCWFU 71117
P30CA012197
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have a histologically or cytologically confirmed Grade II or III softtissue sarcoma that is considered to be resectable and are candidates for pre-opradiation.

  • Age greater than or equal to 18 years. No children will be enrolled on thisprotocol.

  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to

  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to studyentry and for the duration of study participation. Should a woman become pregnant orsuspect she is pregnant while participating in this study, she should inform hertreating physician immediately.

  • Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion

Exclusion Criteria:

  • Patients taking concurrent hormonal therapy, biologic or other chemotherapy areexcluded 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 theaffected extremity.

  • Patients with sarcoma subtypes for which established chemotherapeutic regimensexist.

  • History of radiation to the limb.

Study Design

Total Participants: 27
Treatment Group(s): 5
Primary Treatment: Blood draws
Phase: 1
Study Start date:
August 18, 2020
Estimated Completion Date:
September 30, 2025

Study 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 the extremities.

Secondary Objective:

• To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment.

Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.

Connect with a study center

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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