5-day preoperative radiation for soft tissue sarcoma
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
This study tests whether a shorter, five-day radiation treatment before surgery can safely help people with soft tissue sarcoma in their arms, legs, or abdomen just as well as the usual longer treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06087861 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of a shortened, five-day course of preoperative radiation therapy for patients diagnosed with soft tissue sarcoma located in the extremities, trunk, or retroperitoneum. This approach contrasts with the traditional 25-day radiation regimen, aiming to determine if a more condensed treatment can yield similar or improved outcomes. Participants will receive external beam radiotherapy as part of their preoperative care before surgical intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed soft tissue sarcoma who are scheduled for preoperative radiation and surgery.
Not a fit: Patients with a history of prior radiation to the treatment area or those currently undergoing other anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and less burdensome preoperative treatment option for patients with soft tissue sarcoma.
How similar studies have performed: While the approach of abbreviated radiation therapy is being explored in various contexts, this specific five-day regimen for soft tissue sarcoma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum. 2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment 3. Age ≥ 18 4. KPS ≥ 70 or ECOG 0 to 2 5. Life expectancy ≥ 6 months 6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented. 7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: 1. History of prior radiation to the area to be treated. 2. Active use of other anti-cancer investigational agents. 3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery). 4. Pregnancy.
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Anusha Kalbasi, MD — Stanford University
- Study coordinator: Alyssa Yauger
- Email: ayauger@stanford.edu
- Phone: 650-498-5271
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.