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New radiation patch implanted during surgery aims to stop sarcoma from coming back

NCT ID NCT04033081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called CivaSheet, a permanent radiation patch placed inside the body during surgery to kill any remaining sarcoma cells. About 100 people with sarcoma in the abdomen, pelvis, or trunk will be followed for 5 years to see how safe it is and whether it helps prevent the cancer from returning. The main focus is on serious side effects and how well the radiation targets the right area.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CivaSheet (a permanent radiation implant placed during surgery to target leftover cancer cells)
What this could lead to
If successful, this could provide a new way to reduce sarcoma recurrence after surgery by delivering targeted radiation directly to the tumor bed.
What could go wrong
This is a single-arm registry, not a randomized trial, so it cannot prove the device is better than standard care. Risks include radiation-related side effects and the need for additional surgeries.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

Apr 2020

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Subject Signed Inform Consent 2. Subject plans to remain in the long-term care of his/her enrolling center/investigators. 3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate. 4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk 5. Subject is able to undergo surgery Exclusion Criteria: 1. Is unable or unwilling to comply with protocol requirements. 2. Is enrolled in another study/registry not approved by CivaTech Oncology. 3. Pregnancy, breast feeding

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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.

Contacts and locations

Locations

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.