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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04037527
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : January 27, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Gemcitabine Drug: Docetaxel Radiation: Radiation Procedure: Surgical Resection Other: Blood draws Phase 1

Detailed Description:

Primary Objective:

• To determine the maximum tolerated dose of the neoadjuvant chemotherapy regimen with radiation by evaluating safety using CTCAE v5.0

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: 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)

Drug: 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).
Other Name: Taxotere

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.

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a histologically or cytologically confirmed Grade II or III sarcoma that is considered to be resectable based on standard-of-care guidelines.
  • The sarcoma must be high grade or poorly differentiated.
  • Patients must have measurable disease, defined as at least one lesion with at least one dimension greater than 5 cm.
  • Age >18 years. No children will be enrolled on this protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 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.

Exclusion Criteria:

  • Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded.
  • 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
  • History of radiation to the limb.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04037527

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Contact: Ashley Fansler, RN 336-716-5440

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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         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Principal Investigator: Shailaja Raj, MRCP Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT04037527    
Other Study ID Numbers: IRB00061621
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU 71117 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Grade II sarcoma
Grade III sarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators