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New radiation combo aims to shrink sarcomas before surgery

NCT ID NCT01659203

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Dec 2012

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Washington University School of Medicine Siteman Cancer Center South County

    RECRUITING

    St Louis, Missouri, 63129, United States

  • Washington University School of Medicine Siteman Cancer Center West County

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

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