MedTrace Logo

Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)

NCT01854554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-02

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.

IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues.

IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.

Conditions

Interventions

RADIATION

IMPT

IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

RADIATION

IMRT

IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

BEHAVIORAL

Cognitive Tests

Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.

BEHAVIORAL

Questionnaires

Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Caroline Chung, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-17
Primary Completion
2021-10-13
Completion
2021-10-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854554 on ClinicalTrials.gov