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NCT04037527 | RECRUITING | Soft Tissue Sarcoma

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

Wake Forest University Health Sciences

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.

Condition or disease

Soft Tissue Sarcoma

Intervention/treatment

Gemcitabine

Docetaxel

Radiation

Surgical Resection

Blood draws

Phase

PHASE1

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 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 27 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2020-08-18
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

Location Details

NCT04037527

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How to Participate

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Locations

RECRUITING

United States, North Carolina

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157