Gemcitabine + Docetaxel + Radiation for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking any concurrent hormonal therapy, biologic, or other chemotherapy, except for women on hormonal contraceptives. If you are taking an investigational agent, you will also need to stop.
Is the combination of Gemcitabine and Docetaxel safe for treating soft tissue sarcoma?
How is the drug combination of Gemcitabine and Docetaxel unique for treating soft tissue sarcoma?
The combination of Gemcitabine and Docetaxel is unique for treating soft tissue sarcoma because it offers a potential option when tumors become resistant to standard drugs like doxorubicine and ifosfamide. This combination has shown promising anti-tumor activity, especially in leiomyosarcomas, and is generally well tolerated, although more research is needed to confirm its benefits.12367
What data supports the effectiveness of the drug combination Gemcitabine and Docetaxel for treating soft tissue sarcoma?
Research shows that the combination of Gemcitabine and Docetaxel is effective for patients with metastatic soft tissue sarcoma, particularly in types like leiomyosarcoma and undifferentiated high-grade pleomorphic sarcoma. This combination is considered a useful option, although its effectiveness compared to other treatments like doxorubicin is still being evaluated.12368
Who Is on the Research Team?
Shailaja Raj, MRCP
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Adults over 18 with Grade II or III soft tissue sarcoma that can be surgically removed and are eligible for pre-op radiation. They must have an ECOG performance status of 2 or less, agree to use contraception, and not be pregnant. Excluded are those on other cancer treatments, prior unplanned surgery on the limb, needing amputation, or with specific sarcoma subtypes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy Plus Radiation Therapy
Participants receive up to 6 cycles of chemotherapy with a 3+3 dose escalating plan along with radiation for up to 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Long term follow-up will occur every 3-4 months for 24 months in person or video consultation
What Are the Treatments Tested in This Trial?
Interventions
- Docetaxel
- Gemcitabine
- Radiation
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Cancer Institute (NCI)
Collaborator