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New radiation method aims to protect scalp in brain tumor patients

NCT ID NCT03251027

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a precise type of radiation therapy (IM-SRT) for people with newly diagnosed grade II to IV gliomas. The goal is to deliver a high dose of radiation directly to the tumor while minimizing damage to the scalp, which may reduce wound infections and the need for metal implants after surgery. About 100 participants will receive this treatment and be monitored for complications and quality of life.

What this could mean

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

Active substance
Intensity-modulated stereotactic radiotherapy (IM-SRT)
What this could lead to
If successful, this approach could reduce wound infections and the need for titanium implants after brain tumor surgery, improving recovery and quality of life.
What could go wrong
This is a single-arm phase II trial with 100 participants, so results may not apply to all patients. The technique may not control the tumor as well as standard radiation, and scalp-sparing benefits are not yet proven.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Jul 2017

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: * Patients must have histologically confirmed low or high grade glioma (grade II-IV) * Karnofsky performance status (KPS) \>= 60 * Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment * Estimated survival \>= 3 months * Labs considered acceptable per standard of care * Patient must sign a study specific informed consent form * Radiation treatment must begin \>= 3 weeks and =\< 8 weeks after surgery Exclusion Criteria: * Prior history of scalp radiation or intolerance to standard course of radiation treatment * Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use) * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception * Karnofsky performance status (KPS) \< 60 * Patient can't have magnetic resonance imaging (MRI) scan * Active collagen vascular disease

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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

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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