Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial

This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.

Study Overview

• Status: Completed
• Conditions: Glioblastoma; Recurrent Brain Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Radiation: Palliative Radiation Therapy; Radiation: Radiation Therapy Treatment Planning and Simulation

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the accuracy of dose delivery and patient comfort with treatment time.

II. To evaluate normal tissue dose volume statistics and compare to standard planning.

OUTLINE:

Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.

After completion of study treatment, patients are followed up at 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed primary glioblastoma multiforme (GBM)
• Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
• Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
• Karnofsky Performance Status (KPS) >= 70
• Ability to understand and willingness to sign a written informed consent

• If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment

  • For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)

Exclusion Criteria:

• Patients with active infection
• Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times
• Refusal to sign informed consent
• Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
• Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (4pi radiotherapy); Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.	Other: Questionnaire Administration; Ancillary studies; Radiation: Palliative Radiation Therapy; Undergo 4pi palliative radiotherapy; Radiation: Radiation Therapy Treatment Planning and Simulation; Undergo 4pi radiation simulation and planning; Other Names: Radiation Therapy Treatment Planning/Simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of dose delivery	The accuracy of dose delivery by 4pi will be compared to standard procedures. Standard quality assurance (QA) procedures will be employed to validate the delivery accuracy of 4pi. Specifically, a MatriXX phantom will be employed to measure the dose in both the coronal and sagittal planes and compared to calculation. Patients with QA results showing gamma passing rates (using 3% and 3 mm dose difference and distance to agreement criteria, respectively) less than 90% in either plane or a maximum single gamma value greater than 2 will not be treated until the source of error is corrected.	Up to 6 weeks
Normal tissue dose volume	Statistics will be compared between 4pi and standard planning. Specifically, dose to organs-at-risk (OAR) and planning target volume (PTV) coverage will be compared to assess for improved OAR sparing and improved PTV coverage with 4pi planning.	Up to 6 weeks
Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction		Up to 10 days

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tania Kaprealian, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2014
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 12, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioblastoma; Recurrence; Brain Neoplasms
• Other Study ID Numbers: 14-001086 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); P30CA016042 (U.S. NIH Grant/Contract); NCI-2015-01449 (Registry Identifier: CTRP (Clinical Trial Reporting Program))