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Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Primary Purpose

Glioblastoma, Recurrent Brain Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Radiation Therapy
Questionnaire Administration
Radiation Therapy Treatment Planning and Simulation
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (4pi radiotherapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction

Secondary Outcome Measures

Full Information

First Posted
October 12, 2015
Last Updated
February 26, 2019
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02575027
Brief Title
Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
Official Title
4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Recurrent Brain Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (4pi radiotherapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Palliative Radiation Therapy
Intervention Description
Undergo 4pi palliative radiotherapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy Treatment Planning and Simulation
Other Intervention Name(s)
Radiation Therapy Treatment Planning/Simulation
Intervention Description
Undergo 4pi radiation simulation and planning
Primary Outcome Measure Information:
Title
Accuracy of dose delivery
Description
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.
Time Frame
Up to 6 weeks
Title
Normal tissue dose volume
Description
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.
Time Frame
Up to 6 weeks
Title
Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction
Time Frame
Up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Kaprealian
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

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