Shorter radiation treatment followed by surgery for soft tissue sarcomas
Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
PHASE2 · Vanderbilt-Ingram Cancer Center · NCT04506008
This study is testing if a shorter radiation treatment followed by surgery can help people with soft tissue sarcomas while causing fewer side effects.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04506008 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of neoadjuvant hypofractionated radiotherapy followed by surgical resection in patients with soft tissue sarcomas. Participants will receive either ultra-hypofractionated radiotherapy over 5 days or moderately hypofractionated radiotherapy over 15 days, aiming to reduce the overall treatment duration compared to traditional methods. The study will assess the efficacy of these approaches in achieving local control of the disease and evaluate the side effects and complication rates associated with the treatments. Patients will be monitored for a minimum of two years post-treatment to gather comprehensive data on outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with a histologic diagnosis of soft tissue sarcoma located in the extremities, pelvis, chest wall, or trunk/abdominal wall, who have an ECOG performance status of 0-2.
Not a fit: Patients with a history of prior radiation to the treatment area, pregnancy, or active collagen vascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment time for patients with soft tissue sarcomas without compromising safety or effectiveness.
How similar studies have performed: Other studies have shown promise with hypofractionated radiotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location) * ECOG performance status 0-2 * Patient must be deemed able to comply with radiation treatment and surgery Exclusion Criteria: * History of prior radiation to the same area to be irradiated * Pregnancy * Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Eric Shinohara, MD — Vanderbilt Medical Center
- Study coordinator: Vanderbilt-Ingram Service for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
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: Soft Tissue Sarcomas, Hypofractionated Radiotherapy