A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)
Overview
- Phase
- Phase 2
- Intervention
- Radiation
- Conditions
- Glioblastoma
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression.
Detailed Description
This is a single-arm, single-center phase 2 study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to12 months of adjuvant chemotherapy will be screened and enrolled after surgery.
Investigators
Michael Straza, MD, PhD
Assistant Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •Voluntary written consent must be given before performance of any study-related procedure that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Female or male subjects ≥ 18 years old at the time of informed consent.
- •Histologically confirmed new diagnosis of GBM according to updated World Health Organization (WHO) classification criteria.
- •Supratentorial tumor location.
- •Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable).
- •Planned for standard adjuvant chemoradiotherapy of approximately 60 Gy of radiation therapy (RT) , or biologically equivalent dose, according to local practice, and concomitant TMZ chemotherapy (75 mg/m\^2 daily) Any other cytotoxic or biologic antitumor therapy received prior to enrollment will be considered an exclusion.
- •Planned treatment with adjuvant/maintenance TMZ (150 to 200 mg/m\^2 daily x 5 d, q 28 days).
- •All patients with sufficient tissue must have had tissue submitted for O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation determination prior to enrollment.
- •Karnofsky Performance Status Scale ≥
- •Life expectancy greater than at least three months.
Exclusion Criteria
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years. (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Recurrent or multifocal malignant gliomas.
- •Any site of distant disease (i.e., leptomeningeal disease or drop metastases from the GBM tumor site).
- •Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
- •Severe, active comorbidity, defined as follows:
- •Unstable angina at registration.
- •Transmural myocardial infarction within the last six months prior to registration.
- •Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of ≥ 2 mm using the analysis of an EKG performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue.)
- •New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to.
- •Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
Arms & Interventions
Pulsed reduced dose-rate radiotherapy
Chemoradiation, adjuvant chemotherapy.
Intervention: Radiation
Pulsed reduced dose-rate radiotherapy
Chemoradiation, adjuvant chemotherapy.
Intervention: Concurrent Chemotherapy (Temozolomide)
Pulsed reduced dose-rate radiotherapy
Chemoradiation, adjuvant chemotherapy.
Intervention: Adjuvant Chemotherapy (Temozolomide)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Six months
This outcome measure is the number of subjects whose disease has not progressed using the Macdonald Response Criteria, which has the following classifications: complete response, partial response, stable disease and progression.