Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
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|ClinicalTrials.gov Identifier: NCT04037527|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Gemcitabine Drug: Docetaxel Radiation: Radiation Procedure: Surgical Resection Other: Blood draws||Phase 1|
• To determine the maximum tolerated dose of the neoadjuvant chemotherapy regimen with radiation by evaluating safety using CTCAE v5.0
• 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2023|
Experimental: 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 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).
Other Name: 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.
Procedure: Surgical Resection
Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.
Other: Blood draws
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 [ Time Frame: 2 years ]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 Immunological Changes in Blood [ Time Frame: 4 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037527
|Contact: Ashley Fansler, RNemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Ashley Fansler, RN|
|Principal Investigator: Shailaja Raj, MRCP|
|Principal Investigator:||Shailaja Raj, MRCP||Wake Forest University Health Sciences|