NCT03251027

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2017Dec 2027

Study Start

First participant enrolled

July 17, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

10.5 years

First QC Date

August 14, 2017

Last Update Submit

January 23, 2026

Conditions

WHO Grade III GliomaGlioblastomaWHO Grade II Glioma

Outcome Measures

Primary Outcomes (1)

  • Incidence of wound infection or wound dehiscence

    Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.

    Up to 2 years

Secondary Outcomes (4)

  • Incidence of titanium implants

    Up to 2 years

  • Incidence of hair loss

    Up to 2 years

  • Incidence of recovery rate

    Up to 2 years

  • Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire

    Up to 2 years

Other Outcomes (1)

  • Scalp thickness

    Up to 18 months

Study Arms (1)

Treatment (IM-SRT)

EXPERIMENTAL

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

Radiation: Intensity-Modulated Radiation TherapyOther: Quality-of-Life

Interventions

Intensity-Modulated Radiation TherapyRADIATION

Undergo IM-SRT

Treatment (IM-SRT)
Quality-of-LifeOTHER

Ancillary studies

Also known as: Quality of Life Assessment, Quality-of-Life Assessment
Treatment (IM-SRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Niazi M, Russial O, Cappelli L, Miller R, Chen Y, Vakhnenko Y, Liu H, Shi W. Efficacy of scalp-sparing volumetric-modulated arc therapy approach in reducing scalp radiation dose for patients with glioblastoma: a cross-sectional study. Chin Clin Oncol. 2023 Aug;12(4):36. doi: 10.21037/cco-23-15.

    PMID: 37699601DERIVED

Related Links

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy, Intensity-ModulatedQuality of Life

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Wenyin Shi, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

July 17, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

US(1)