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Trial record 1 of 1 for:    NCT01854554
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Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01854554
First received: May 13, 2013
Last updated: August 11, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention Phase
Brain Cancer
Radiation: IMPT
Radiation: IMRT
Behavioral: Cognitive Tests
Behavioral: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Cognitive Failure [ Time Frame: 4 months ]
    Time to cognitive failure on any of 6 primary variables from pre-specified cognitive tests (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, TMT Part A or Part B, COWA) with failure defined as a decline that meets or exceeds the reliable change index (RCI) for each cognitive test variable. A cumulative incidence approach used to estimate median time to cognitive failure in order to account for the competing risks of disease progression and death.


Secondary Outcome Measures:
  • Local Control in the Brain Post Radiation Treatment [ Time Frame: 4 months after radiation treatment ]
    Local control in the brain will be measured by contrast-enhanced brain MRI scan using Response Assessment in Neuro-Oncology (RANO) Criteria.


Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensity Modulated Proton Radiotherapy (IMPT)
IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
Radiation: IMPT
IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
Other Names:
  • Radiotherapy
  • XRT
Behavioral: Cognitive Tests
Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.
Other Name: Thinking skills tests
Behavioral: Questionnaires
Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.
Other Name: Surveys
Experimental: Intensity Modulated Radiotherapy (IMRT)
IMRT 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.
Other Names:
  • Radiotherapy
  • XRT
Behavioral: Cognitive Tests
Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.
Other Name: Thinking skills tests
Behavioral: Questionnaires
Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
  2. All patients must be >/=18 years of age.
  3. All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is the one approved by MD Anderson IRB.
  4. All patients must have a baseline Mini Mental Status Examination score >/=21.
  5. All patients must have a KPS >/=70.
  6. All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
  7. All patients must be able to undergo MRI with and without contrast with a glomerular filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m2.
  8. All patients must have adequate liver, renal, and hematologic function within 14 days of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase < 3 times normal, creatinine </=1.7 mg/dl, BUN </= 35mg/dl, absolute neutrophil count >/=1,800 cells/mm3, Hemoglobin >/= 10 g/dl, and platelet count > 100,000.
  9. All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments. However mild to moderate deficits in these functions due to tumor are allowed.

Exclusion Criteria:

  1. Patients will be excluded if they are not planning to receive concurrent temozolomide.
  2. Patients will be excluded if they have had prior radiation to the brain.
  3. Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
  4. Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential.
  5. Patients with gliomatosis will be excluded.
  6. Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
  7. Patients weighing greater than 136 kilograms will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854554

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul Brown, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01854554     History of Changes
Other Study ID Numbers: 2013-0097
NCI-2013-01089 ( Registry Identifier: NCI CTRP )
Study First Received: May 13, 2013
Last Updated: August 11, 2016

Keywords provided by M.D. Anderson Cancer Center:
Brain cancer
Glioblastoma
Glioblastoma Multiforme
GBM
Intensity Modulated Proton Radiotherapy
IMPT
Intensity Modulated Radiotherapy
IMRT
Radiotherapy
XRT
Cognitive tests
Thinking skills tests
Questionnaires
Surveys
Quality of life
QOL

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on March 29, 2017