Clinical trial NCT02575027: Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
Official title: 4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Recurrent Brain Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Accuracy of dose delivery
timeFrame: Up to 6 weeks
measure: Normal tissue dose volume
timeFrame: Up to 6 weeks
measure: Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction
timeFrame: Up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Tania Kaprealian
role: PRINCIPAL_INVESTIGATOR
References: