5-day radiation therapy before surgery for soft tissue sarcomas
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
NA · Jonsson Comprehensive Cancer Center · NCT02701153
This study is testing if a shorter, stronger course of radiation therapy before surgery can help people with recurring soft tissue sarcomas do better and have fewer side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT02701153 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effects of hypofractionated radiation therapy on patients with recurrent adult soft tissue sarcomas prior to surgical intervention. The approach involves delivering higher doses of radiation over a shorter time frame, which may enhance tumor cell destruction while minimizing side effects. The study aims to assess radiation-related morbidity, local and regional control of the disease, and overall survival rates, alongside functional outcomes and genetic factors influencing cancer predisposition. Patients will receive radiation therapy for five consecutive days, followed by surgery 2-12 weeks later, with follow-up assessments conducted for five years.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed, resectable soft tissue sarcomas of intermediate or high grade, particularly those who have not received prior radiation therapy.
Not a fit: Patients with active treatment for another malignancy or a history of prior irradiation to the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and reduce side effects for patients with soft tissue sarcomas.
How similar studies have performed: Other studies have shown promise with hypofractionated radiation therapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed soft tissue sarcoma of the extremity/trunk * Intermediate or high grade sarcoma * Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected) * Recurrent, any grade, no previous radiation therapy * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2 * If a woman is of childbearing potential, a negative serum pregnancy test must be documented Exclusion Criteria: * Active treatment of a separate malignancy * History of prior irradiation to the area to be treated * Pre-operative chemotherapy (post-op acceptable)
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Anusa Kalbasi, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Jackie Hernandez
- Email: jhernandez@mednet.ucla.edu
- Phone: 310-206-8477
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.
Conditions: Recurrent Adult Soft Tissue Sarcoma