A Phase 1 interventional study of Gemcitabine and Docetaxel in Soft Tissue Sarcoma, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment
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.
Primary Objective:
Secondary Objective:
Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Gemcitabine · Drug: Docetaxel · Radiation: Radiation · Procedure: Surgical Resection · Other: Blood draws
Gemcitabine will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity on a 3+3 escalating dose (100 mg/m² to 300 mg/m²)
Docetaxel will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity (10 mg/m² to 25 mg/m²).
Also known as: Taxotere
Radiation is to be done with standard preop dose of 50 Gy but at lower doses per fraction. Thus 50.4 Gy in 28 FX. Radiation will be given for 5 days (Monday - Friday) every week for approx. 6 weeks.
Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.
Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.
Maximum Tolerated Dose Chemotherapy and Radiation
Maximum tolerated dose of Gemcitabine and Taxotere and radiation will be completed by monitoring toxicities and using the 3+3 dose escalation plan.
Time frame: Up to 8 weeks
Number of Toxicity Incidences
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.
Time frame: 8 weeks post-surgery
Number of Immunological Changes in Blood
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.
Time frame: 8 weeks post-surgery
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Plan to share: No
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences