Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Completed · Not applicable

Conditions studied: Glioblastoma, Recurrent Brain Neoplasm

In brief

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.

Key facts

Study ID

NCT02575027

Run by

Jonsson Comprehensive Cancer Center

People needed

10

Starts

2014-11-12

Expected to finish

2018-06-20

Last updated by the study team

2019-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.