New radiation combo aims to shrink sarcomas before surgery
NCT ID NCT01659203
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests two types of radiation therapy—proton beam or advanced photon (IMRT)—given before surgery for retroperitoneal sarcoma, a rare tumor deep in the abdomen. The goal is to find the highest safe dose that can be delivered to high-risk areas of the tumor while protecting healthy tissue. About 80 adults with this sarcoma will receive daily radiation for six weeks, then undergo surgery. The trial first checks safety, then measures how well the treatment controls the tumor locally.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton beam radiation therapy or intensity-modulated photon radiation therapy (IMRT)
- What this could lead to
- If successful, this could establish a safer, more effective radiation approach before surgery for retroperitoneal sarcoma, potentially reducing side effects and improving tumor control.
- What could go wrong
- This is an early-phase trial (Phase I/II) with only 80 participants, so results may not apply broadly. Radiation can still damage nearby organs, and the higher dose boost may increase toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Dec 2012
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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Duke University
RECRUITINGDurham, North Carolina, 27710, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55902, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
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Washington University School of Medicine Siteman Cancer Center South County
RECRUITINGSt Louis, Missouri, 63129, United States
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Washington University School of Medicine Siteman Cancer Center West County
RECRUITINGCreve Coeur, Missouri, 63141, United States
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