Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

NCT02575027 | Completed DMC

• 3 other identifiers: 14-001086NCI-2015-01449P30CA016042
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Recurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Treatment (4pi radiotherapy)

EXPERIMENTAL

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.

Radiation: Palliative Radiation Therapy; Other: Questionnaire Administration; Radiation: Radiation Therapy Treatment Planning and Simulation

Interventions

Palliative Radiation Therapy RADIATION

Undergo 4pi palliative radiotherapy

Treatment (4pi radiotherapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (4pi radiotherapy)

Radiation Therapy Treatment Planning and Simulation RADIATION

Undergo 4pi radiation simulation and planning

Also known as: Radiation Therapy Treatment Planning/Simulation

Treatment (4pi radiotherapy)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Tania Kaprealian

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 14, 2015
• Study Start: November 12, 2014
• Primary Completion: June 20, 2018
• Study Completion: June 20, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

US (1)