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

Phase 1

Recruiting

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: Gemcitabine; Drug: Docetaxel; Radiation: Radiation; Procedure: Surgical Resection; Other: Blood draws

• Registration Number: NCT04037527
• Lead 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.

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 Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2020-08-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemotherapy Plus Radiation Therapy	Surgical Resection	Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.
Neoadjuvant Chemotherapy Plus Radiation Therapy	Blood draws	Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.
Neoadjuvant Chemotherapy Plus Radiation Therapy	Radiation	Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.
Neoadjuvant Chemotherapy Plus Radiation Therapy	Docetaxel	Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.
Neoadjuvant Chemotherapy Plus Radiation Therapy	Gemcitabine	Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose Chemotherapy and Radiation	Up to 8 weeks	Maximum tolerated dose of Gemcitabine and Taxotere and radiation will be completed by monitoring toxicities and using the 3+3 dose escalation plan.
Number of Toxicity Incidences	8 weeks post-surgery	Complication/side effects from the chemotherapy combination of gemcitabine and taxotere concurrent with radiation will be assessed by toxicity counts/rates presented descriptively by toxicity, severity, and dose level using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

Name	Time	Method
Number of Immunological Changes in Blood	8 weeks post-surgery	The effects of the treatment on the immune system will be analyzed using paired t-test or the non-parametric counterpart. Correlations between immune cells and immune factor levels will be assessed using Spearman correlation coefficient. All tests will be two-sided with a significance level of 0.05, and no adjustment for multiple comparisons will be made due to the exploratory nature of these studies.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States