Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Glioblastoma Clinical Trial

Official title:

4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575027
• Other study ID #: 14-001086
• Secondary ID: NCI-2015-0144914
• Status: Completed
• Phase: N/A
• Start date: November 12, 2014
• Est. completion date: June 20, 2018

Study information

• Verified date: February 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioblastoma
• Recurrent Brain Neoplasm

Intervention

Radiation:
• Palliative Radiation Therapy
Undergo 4pi palliative radiotherapy

Other:
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy Treatment Planning and Simulation
Undergo 4pi radiation simulation and planning

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction		Up to 10 days