Comparing proton and photon radiation for treating retroperitoneal sarcomas
Official title: 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
Run by Massachusetts General Hospital · NCT01659203 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Status | Recruiting |
| Started | December 2012 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT01659203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically proven primary soft tissue sarcoma of the retroperitoneum and a life expectancy of over two years.
✕Probably not a fit
Patients with prior radiation therapy for retroperitoneal sarcoma or those with multifocal disease or metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with proton therapy in various cancers, suggesting potential for success in this novel application for retroperitoneal sarcomas.
Who can join: the full rules
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 it's running
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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
Show 4 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Personalised neoadjuvant therapy planning for adults with high‑risk soft tissue sarcoma
This project tests whether analyzing tumor tissue and clinical data can help guide neoadjuvant chemotherapy decisions for adults with high‑risk soft tissue sarcomas.
-
Assessing colorectal resections in patients with retroperitoneal sarcoma
This study is trying to see how different surgical techniques for removing retroperitoneal sarcomas affect patients' recovery and quality of life.
-
Short course radiation treatment for retroperitoneal sarcoma before surgery
This study is testing a shorter radiation treatment for patients with retroperitoneal sarcoma to see if it can be safely used before surgery.
-
Electrochemotherapy for unresectable visceral tumors including liver metastases
This will try electrochemotherapy with bleomycin in adults who have unresectable primary or metastatic visceral tumors, such as liver metastases.
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Proton therapy combined with standard radiation for treating retroperitoneal sarcoma
This study is testing a new type of radiation therapy combined with standard treatment to see if it helps people with newly diagnosed retroperitoneal sarcoma before they have surgery.
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Using Abemaciclib and Radiation Therapy Before Surgery for High-Risk Retroperitoneal Sarcoma
This study is testing if taking a medication called abemaciclib along with radiation therapy before surgery can help shrink tumors in patients with high-risk retroperitoneal sarcoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.