Comparing proton and photon radiation for treating retroperitoneal sarcomas
Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
PHASE1; PHASE2 · Massachusetts General Hospital · NCT01659203
This study is testing whether proton beam radiation is safer and more effective than regular radiation for treating patients with retroperitoneal sarcomas before their surgery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Trial ID | NCT01659203 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and appropriate dosing of proton beam radiation therapy and intensity-modulated radiation therapy (IMRT) for patients with retroperitoneal sarcomas. Participants will receive radiation therapy daily for about six weeks before undergoing surgery to remove their tumors. The study aims to minimize damage to normal tissue while effectively targeting the tumors. Additionally, blood samples may be collected for further genomic analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically proven primary soft tissue sarcoma of the retroperitoneum and a life expectancy of over two years.
Not a fit: Patients with prior radiation therapy for retroperitoneal sarcoma or those with multifocal disease or metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective radiation treatment options for patients with retroperitoneal sarcomas.
How similar studies have performed: Other studies have shown promise with proton therapy in various cancers, suggesting potential for success in this novel application for retroperitoneal sarcomas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven primary soft tissue sarcoma of the retroperitoneum * Measurable disease * Life expectancy of greater than 2 years Exclusion Criteria: * Prior radiation therapy for retroperitoneal sarcoma * Pregnant or breastfeeding * Chemotherapy within 4 weeks prior to entering study * Receiving other investigational agents * Other types of sarcomas * Multifocal disease, lymph node or distant metastases * History of sensitivity to radiation therapy * Uncontrolled intercurrent illness * History of a different invasive malignancy within the past 3 years * HIV positive on combination anti-retroviral therapy
Where this trial is running
Chicago, Illinois and 9 other locations
- Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Washington University School of Medicine Siteman Cancer Center West County — Creve Coeur, Missouri, United States (RECRUITING)
- Washington University School of Medicine Siteman Cancer Center South County — St Louis, Missouri, United States (RECRUITING)
- Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)
- Duke University — Durham, North Carolina, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Thomas F. DeLaney, M.D. — Massachusetts General Hospital
- Study coordinator: Thomas DeLaney, MD
- Email: tdelaney@partners.org
- Phone: 617-726-6876
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: Retroperitoneal Sarcoma, extraskeletal chondrosarcoma