Combining gemcitabine and docetaxel with radiation for soft tissue sarcoma treatment
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
This study is testing if combining two chemotherapy drugs with radiation can safely improve treatment for adults with certain types of soft tissue sarcoma in their arms or legs.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04037527 on ClinicalTrials.gov |
What this trial studies
This Phase 1 research focuses on assessing the safety and effectiveness of administering gemcitabine and docetaxel alongside radiation therapy in adults with Grade II or III soft tissue sarcoma of the extremities. The primary objective is to identify the maximum tolerated doses of these drugs when given weekly in a neoadjuvant setting. Additionally, the study aims to evaluate immunological changes in patients' blood, including various immune cell subsets, to understand the tumor microenvironment better. Participants will undergo long-term follow-up every 3-4 months for two years, either in person or via video consultations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed Grade II or III soft tissue sarcoma that is resectable and eligible for pre-operative radiation.
Not a fit: Patients currently undergoing hormonal therapy, biologic treatments, or other chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk soft tissue sarcomas.
How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating soft tissue sarcomas with chemotherapy and radiation.
Eligibility criteria
Show full inclusion / exclusion criteria
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-op radiation. * 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 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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shailaja Raj, MRCP — Wake Forest University Health Sciences
- Study coordinator: Ashley Fansler, RN
- Email: arcarrol@wakehealth.edu
- Phone: 336-716-5440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.