Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00099125

Brain and Central Nervous System Tumors

COMPLETED PHASE2

Stereotactic Radiosurgery in Treating Patients With Brain Tumors

NCT00019578

Adult Central Nervous System Germ Cell Tumor Adult Malignant Meningioma Adult Medulloblastoma +11 more

COMPLETED PHASE1

Using Intensity Modulated Radiation Therapy (IMRT) for Brain Metastases

NCT00328575

Neoplasm Metastasis

COMPLETED PHASE1

Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

NCT00253448

Brain and Central Nervous System Tumors

COMPLETED PHASE2

Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT02179086

Glioblastoma

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous \[IV\] antibiotics or surgery), or wound dehiscence.

SECONDARY OBJECTIVES:

I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning.

II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.

III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

TERTIARY OBJECTIVES:

I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma WHO Grade II Glioma WHO Grade III Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (IM-SRT)

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Group Type EXPERIMENTAL

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IM-SRT

Quality-of-Life

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensity-Modulated Radiation Therapy

Undergo IM-SRT

Intervention Type RADIATION

Quality-of-Life

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Quality of Life Assessment Quality-of-Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No