Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
NCT ID: NCT04037527
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2020-08-18
2024-06-18
Brief Summary
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Detailed Description
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• 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neoadjuvant Chemotherapy Plus Radiation Therapy
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.
Gemcitabine
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
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).
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.
Surgical Resection
Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.
Blood draws
Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.
Interventions
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Gemcitabine
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
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).
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.
Surgical Resection
Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.
Blood draws
Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Shailaja Raj, MRCP
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU 71117
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00061621
Identifier Type: -
Identifier Source: org_study_id