Glioblastoma Multiforme
Conditions
Brief summary
This study aims to analyze the role the of Regorafenib in prolonging the Overall Survival of glioblastoma multiforme patients who progressed after surgery and a first-line chemo-radiotherapy treatment in the setting of real world life.
Detailed description
The primary aim of the study
Interventions
DRUGRegorafenib 40 MG Oral Tablet [STIVARGA]
As per the treating physicians discretion
Sponsors
Istituto Oncologico Veneto IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age * Histologically confirmed glioblastoma (grade IV) * First recurrence after adjuvant treatment (surgery followed by radiotherapy and temozolomide chemotherapy) in patients who have not received further therapeutic interventions * World Health Organization (WHO) Performance status ≤ 1 (or Karnofsky performance status (KPS) ≥70)) before the start of the treatment * Documented progression of disease as defined by RANO criteria at least 12 weeks after completion of radiotherapy, unless the recurrence is outside the radiation field or has been histologically documented. * Documented progression of disease by a brain MRI scan done within 14 days before the start of treatment with Regorafenib. * Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan. * Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment: * Hemoglobin \>9.0 g/dl * Absolute neutrophil count (ANC) \>1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors * Platelet count ≥100,000/μl * White blood cell count (WBC) \>3.0 x 109/L * Total bilirubin \<1.5 times the upper limit of normal * ALT and AST \<3 x upper limit of normal * Serum creatinine \<1.5 x upper limit of normal * Alkaline phosphatase \<2.5 x ULN (\<5 x upper limit of normal value) * PT-INR/PTT \<1.5 x upper limit of normal * Lipase ≤ 1.5 x the ULN * Glomerular filtration rate ≥ 30 mL/min/1.73 m2 * TSH, fT3,fT4 within normal limits * Patients may have undergone surgery for the recurrence; the histological report must document a glioblastoma recurrence. If operated: * at least 28 days from the surgery is required prior to Regorafenib administration and patients should have fully recovered.
Exclusion criteria
* Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor * Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of treatment * Recurrent disease located outside of the brain * Have uncontrolled hypertension (systolic blood pressure \[SBP\] \> 140 mmHg or diastolic blood pressure \[DBP\] \> 90 mmHg) despite optimal medical management * Have had a myocardial infarction \< 6 months prior to initiation of treatment with Regorafenib * Have had arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of treatment with Regorafenib * Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy * Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months | Overall Survival is defined as the time from date of enrolment to the date of death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months | from the date of enrolment to the date of disease progression determined using RANO criteria or to the date of death, whichever occurs first. |
| Objective response rate (ORR) | Approximately 24 months | As percentage of patients achieving a complete response plus partial response |
| Disease control rate (DCR) | Approximately 24 months | As percentage of patients achieving a complete response plus partial response plus stable disease. |
| Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0) | From the start of Regorafenib treatment up to 30 days after the end of treatment | Toxicity during the treatment will be recorded and graded according to the NCICommon Terminology Criteria for Adverse Events (CTCAE) v.4.. , related to severity of the adverse event from Grade 1 to Grade 5 |
Countries
Italy
Outcome results
None listed