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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 71117 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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Terminated due DLTs
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
• 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemotherapy Plus Radiation Therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shailaja Raj, MRCP | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 2, 2025 | Jan 27, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D011827 | Radiation |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Docetaxel | Drug | 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). |
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| Radiation | Radiation | 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. |
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| Surgical Resection | Procedure | Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur. |
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| Blood draws | Other | Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy. |
|
| 8 weeks post-surgery |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D055585 | Physical Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |