Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

NCT00681473 | Completed Results DMC

• 1 other identifier: 06-195
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.

Conditions

Low Grade Gliomas

Keywords

proton radiation therapy; photon radiation therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Late Effects > 3 Months Post RT

  5 years

Secondary Outcomes (2)

• Percentage of Participants With Progression Free Survival

  At 1, 3, and 5 years

• Percentage of Participants With Overall Survival

  At 1, 3, and 5 years

Study Arms (1)

Proton Radiation Therapy

EXPERIMENTAL

Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.

Radiation: Proton Radiation Therapy

Interventions

Proton Radiation Therapy RADIATION

Once daily, Monday through Friday, for 6 weeks.

Proton Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
• Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
• KPS of 70 or greater
• years of age or older
• Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
• Must be able to speak and comprehend English

You may not qualify if:

• Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
• Prior history of cranial irradiation
• Pregnancy at the time of radiation treatment
• Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
• Comorbid illness or reason to suggest a life expectancy of less than 5 years

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Protons

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Results Point of Contact

• Title: Helen A. Shih, MD
• Organization: Massachusetts General Hospital

HSHIH@Partners.org

617-724-9627

Study Officials

• Helen A. Shih, MD, MS, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 19, 2008
• First Posted: May 21, 2008
• Study Start: July 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 7, 2017
• Results First Posted: January 9, 2017

Record last verified: 2017-01

Locations

US (1)