Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

NCT ID: NCT02575027

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-12
• Study Completion Date: 2018-06-20

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.

Conditions

Glioblastoma; Recurrent Brain Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palliative Radiation Therapy

Intervention Type: RADIATION

Undergo 4pi palliative radiotherapy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Radiation Therapy Treatment Planning and Simulation

Intervention Type: RADIATION

Undergo 4pi radiation simulation and planning

Interventions

Palliative Radiation Therapy

Undergo 4pi palliative radiotherapy

Intervention Type: RADIATION

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Radiation Therapy Treatment Planning and Simulation

Undergo 4pi radiation simulation and planning

Intervention Type: RADIATION

Other Intervention Names

Radiation Therapy Treatment Planning/Simulation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania Kaprealian

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2015-01449

Identifier Type: REGISTRY

Identifier Source: secondary_id

14-001086

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016042

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-001086

Identifier Type: -

Identifier Source: org_study_id