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

NCT01854554 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: 2013-0097NCI-2013-01089
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Brain Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to Cognitive Failure

  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.

  baseline, 4 months, then every 2 months for 2 years

Secondary Outcomes (3)

• Overall Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Progression Free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Number of Participants Experienced Adverse Events by Maximum Grade (Grade 2 or Higher)

  2 years

Study Arms (2)

Intensity Modulated Proton Radiotherapy (IMPT)

EXPERIMENTAL

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

Radiation: IMPT; Behavioral: Cognitive Tests; Behavioral: Questionnaires

Intensity Modulated Radiotherapy (IMRT)

EXPERIMENTAL

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

Radiation: IMRT; Behavioral: Cognitive Tests; Behavioral: Questionnaires

Interventions

IMPT RADIATION

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

Also known as: Radiotherapy, XRT

Intensity Modulated Proton Radiotherapy (IMPT)

IMRT RADIATION

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

Also known as: Radiotherapy, XRT

Intensity Modulated Radiotherapy (IMRT)

Cognitive Tests BEHAVIORAL

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

Also known as: Thinking skills tests

Intensity Modulated Proton Radiotherapy (IMPT); Intensity Modulated Radiotherapy (IMRT)

Questionnaires BEHAVIORAL

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

Also known as: Surveys

Intensity Modulated Proton Radiotherapy (IMPT); Intensity Modulated Radiotherapy (IMRT)

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
• All patients must be \>/=18 years of age.
• 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.
• All patients must have a baseline Mini Mental Status Examination score \>/=21.
• All patients must have a KPS \>/=70.
• All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
• 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.
• 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.
• 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.

You may not qualify if:

• Patients will be excluded if they are not planning to receive concurrent temozolomide.
• Patients will be excluded if they have had prior radiation to the brain.
• Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
• 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.
• Patients with gliomatosis will be excluded.
• Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
• Patients weighing greater than 136 kilograms will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma

Interventions

Radiotherapy; Neuropsychological Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Psychological Tests; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Caroline Chung, MD- VP, Chief Data Officer, Data Impact & Governance
• Organization: UT MD Anderson Cancer Center

cchung3@mdanderson.org

(713) 745-5422

Study Officials

• Caroline Chung, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: May 17, 2013
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Locations

US (1)