- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810182
Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS
February 7, 2024 updated by: Istituto Oncologico Veneto IRCCS
Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. IOV-GB-1-2020 REGOMA-OSS
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".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary aim of the study
Study Type
Observational
Enrollment (Actual)
192
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Udine, Italy, 33100
- Azienda Sanitaria Universitaria Friuli Centrale
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BA
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Acquaviva Delle Fonti, BA, Italy, 70021
- Ospedale Generale Regionale " F.Miulli "
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Bari, BA, Italy, 70124
- Policlinico Universitario di Bari
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Castellana Grotte, BA, Italy, 70013
- IRCCS "Saverio de Bellis"
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BL
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Belluno, BL, Italy, 32100
- Ospedlae S. Martino
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BO
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Bologna, BO, Italy, 40124
- Ospedale Bellaria
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BR
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Brindisi, BR, Italy, 72100
- Ospedale Perrino
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BS
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Brescia, BS, Italy, 25123
- Università e ASST Spedali Civili
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FC
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Meldola, FC, Italy, 47014
- Irst-Irccs
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FI
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Bagno A Ripoli, FI, Italy, 50012
- OSpedale Santa Maria Annunziata
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Firenze, FI, Italy, 50134
- Azienda Ospedaliera Universitaria Careggi
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LO
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Livorno, LO, Italy, 57100 -
- Ospedale Civile Di Livorno
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MC
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Macerata, MC, Italy, 62100
- Ospedale Generale provinciale
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ME
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Messina, ME, Italy, 98122
- AOU Policlinico "G.Martino"
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MI
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Milano, MI, Italy, 20133
- Istituto Neurologico C. Besta IRCCS
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Rozzano, MI, Italy, 20089
- Ospedale Humanitas
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NL
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Napoli, NL, Italy, 80145
- Ospedale del Mare
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PA
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Cefalù, PA, Italy, 90015
- Fondazione Istiuto Giglio Cefalù
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PD
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Piove Di Sacco, PD, Italy, 35131
- Aulss6 Euganea Padova Sud Ospedali Riuniti
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PI
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Pisa, PI, Italy, 56126
- Azienda Ospedaliero Universitaria di Pisa
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RM
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Roma, RM, Italy, 00144
- Istituto Nazionale Tumori Regina Elena -IFO
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Roma, RM, Italy, 00168
- Policlinico Universitario Gemelli
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RO
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Rovigo, RO, Italy, 45100
- Ospedale di Rovigo
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SI
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Siena, SI, Italy, 53100
- Azienda Ospedaliero Universitaria di Siena
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TO
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Torino, TO, Italy, 10126
- Azienda Ospedaliero Universitaria della Città della Salute e della Scienza
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TR
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Terni, TR, Italy, 05100
- Azienda Ospedaliera Santa Maria
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VE
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San Dona di Piave, VE, Italy, 30027
- Ospedale San Donà di Piave _Azienda ULSS 4 " Veneto Orientale"
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VI
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Santorso, VI, Italy, 36014
- AULSS 7 Distretto 2 Ospedale Santorso
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VR
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Legnago, VR, Italy, 37045
- AULSS 9 Scaligera Ospedale Mater Salutis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with relapse of glioblastoma (grade IV) after surgery and radio-chemotherapy first line treatment, treated with Regorafenib until disease progression or the appearance of unacceptable toxicity.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Glioblastoma Patients treated with Regorafenib
Patients with a confirmed diagnosis of Glioblastoma for whom a decision to treat with regorafenib has been made (by the treating physician).
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As per the treating physicians discretion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months
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Overall Survival is defined as the time from date of enrolment to the date of death due to any cause
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From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months
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from the date of enrolment to the date of disease progression determined using RANO criteria or to the date of death, whichever occurs first.
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From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months
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Objective response rate (ORR)
Time Frame: Approximately 24 months
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As percentage of patients achieving a complete response plus partial response
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Approximately 24 months
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Disease control rate (DCR)
Time Frame: Approximately 24 months
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As percentage of patients achieving a complete response plus partial response plus stable disease.
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Approximately 24 months
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Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0)
Time Frame: From the start of Regorafenib treatment up to 30 days after the end of treatment
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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
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From the start of Regorafenib treatment up to 30 days after the end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2020
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOV-GB-1-2020 REGOMA-OSS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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