NCT01358058

Brief Summary

In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started May 2011

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 Progress91%
May 2011Nov 2027

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

16 years

First QC Date

May 17, 2011

Last Update Submit

December 4, 2025

Conditions

Low Grade GliomaWHO Grade 3 Glioma With IDH1 MutationWHO Grade 3 Glioma With 1p/19q Codeletion

Keywords

Brain tumorsRadiationProtonGliomas

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    To assess progression free survival of this treatment program.

    7 years

Secondary Outcomes (2)

  • Safety and Tolerability

    7 years

  • Overall survival

    7 years

Study Arms (1)

Proton radiation therapy

EXPERIMENTAL

Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))

Radiation: Proton radiation

Interventions

Proton radiationRADIATION

Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.

Proton radiation therapy

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
  • Subject must be indicated for radiation therapy
  • Life expectancy greater than 5 years
  • Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
  • Able to speak and comprehend English
  • Recovered from adverse events due to agents administered more than 4 weeks before entering study
  • Able to undergo MRI scans

You may not qualify if:

  • Prior cranial radiation therapy
  • Chemotherapy within 4 weeks prior to entering study
  • Pregnant or breastfeeding
  • Known brain metastases
  • Baseline neurocognitive or emotional disorders
  • Uncontrolled intercurrent illness
  • History of a different malignancy unless disease-free for at least 5 years
  • HIV positive on antiretroviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Helen A Shih, MD

    Massachusetts General Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Attending Radiation Oncologist

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

US(1)