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Gemcitabine and Docetaxel with Radiation Therapy before Surgery for the Treatment of High Grade and Greater than 5 cm Soft Tissue Sarcoma of the Extremities

Trial Status: Active

This phase I trial investigates the side effects and best dose of gemcitabine and docetaxel when given together with radiation therapy, and to see how well the combination works before surgery in treating patients with high grade soft tissue sarcoma of the upper or lower limbs (extremities) that is over 5 cm in size. Chemotherapy drugs, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving gemcitabine, docetaxel, and radiation therapy to patients with soft tissue sarcoma of the extremities may lead to a reduction in the size of the tumor prior to surgery. It may also lead to better surgical outcomes and / or reduce the risk of the tumor spreading to other parts of the body.

Inclusion Criteria

  • Patients must have a histologically or cytologically confirmed grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-operation (op) radiation
  • 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
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives
  • 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

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Shailaja Ks Raj
Phone: 336-716-7972

PRIMARY OBJECTIVE:

I. To determine the maximum tolerated doses of gemcitabine hydrochloride (gemcitabine) and docetaxel (Taxotere) when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.

SECONDARY OBJECTIVE:

I. To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patients with high risk-soft tissue sarcomas in blood.

OUTLINE: This is a dose-escalation study of gemcitabine and docetaxel.

Patients receive gemcitabine intravenously (IV) over 30 minutes and docetaxel IV over 1 hour on day 1. Patients also undergo concurrent radiation therapy daily Monday-Friday per the radiation oncologist’s recommendations. Treatment repeats every 7 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. 4-5 weeks after the last radiation therapy treatment, patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 8 weeks.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Wake Forest University Health Sciences

Principal Investigator
Shailaja Ks Raj

  • Primary ID WFBCCC 71117
  • Secondary IDs NCI-2020-04227
  • Clinicaltrials.gov ID NCT04037527