Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Glioblastoma

Recurrent Brain Neoplasm

Treatments

Radiation: Palliative Radiation Therapy

Radiation: Radiation Therapy Treatment Planning and Simulation

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02575027

14-001086 (Other Identifier)

P30CA016042 (U.S. NIH Grant/Contract)

NCI-2015-01449 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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