Recurrent High Grade GliomaNCT02567539
Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
A study testing IMRT with or without radiosensitive therapy and Radiosensitive therapy in people with Recurrent High Grade Glioma, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High Grade Glioma
- What is being tested?
- IMRT with or without radiosensitive therapy and Radiosensitive therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Karnosky performance status (KPS) ≥70
- Patients aged >70 years with KPS ≥80
- Histopathologically confirmed grade III-IV glioma
- Estimated survival ≥ 3 months
- Any Tumor volume
Show all 10Show fewer
- Unifocal tumor
- Interval time from previous radiotherapy ≥ 6mesi
- Normal liver, Kidney and bone marrow function
- Written informed consent
Who cannot join
- KPS < 70
- Multifocal tumor
- Other primary cancer
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Read the detailed description
Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.
Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
- Conditions
- Recurrent High Grade Glioma
- Being tested
- IMRT with or without radiosensitive therapy, Radiosensitive therapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT with or without radiosensitive therapyRadiation
Also called Hypofractionated Stereotactic Radiation
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
Radiosensitive therapyDrug
Also called Chemotherapy
Radiosensitive therapy with Temozolomide
| Study group | Role | What they receive |
|---|---|---|
| Recurrent high grade glioma | Experimental | IMRT with or without radiosensitive therapy Receives: Radiation: IMRT with or without radiosensitive therapy; Drug: Radiosensitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free of participants
Measured: 4 years
Overall survival of participants
Measured: 4 years
Secondary outcomes (2)
Incidence of radionecrosis
Measured: 3 months
Questionnaire assessment of neurocognitive function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start27 May 2015
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Piera Navarria, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567539
- Sponsor's protocol ID
- 1394
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2015
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Navarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23.
PubMed 25761491Scorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2.
PubMed 26118437Navarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.
PubMed 34952000
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
- ClinicalTrials.gov ID
- NCT02567539
- Acronym / sponsor ID
- 1394
- Conditions
- Recurrent High Grade Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Detailed description
Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.
Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent high grade glioma | Experimental | Radiation: IMRT with or without radiosensitive therapy, Drug: Radiosensitive therapyIMRT with or without radiosensitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Karnosky performance status (KPS) ≥70
- Patients aged >70 years with KPS ≥80
- Histopathologically confirmed grade III-IV glioma
- Estimated survival ≥ 3 months
Key exclusion criteria (4 listed)
- KPS < 70
- Multifocal tumor
- Other primary cancer
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRT with or without radiosensitive therapyAlso: Hypofractionated Stereotactic RadiationRe-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc | Radiation | Recurrent high grade glioma |
| Radiosensitive therapyAlso: ChemotherapyRadiosensitive therapy with Temozolomide | Drug | Recurrent high grade glioma |
Primary outcome
Progression free of participants
Time frame: 4 years
Overall survival of participants
Time frame: 4 years
2 secondary outcomes
Incidence of radionecrosis
Time frame: 3 months
Questionnaire assessment of neurocognitive function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Results publication: PubMed 25761491Navarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23.
- Results publication: PubMed 26118437Scorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2.
- Derived from this study: PubMed 34952000Navarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piera Navarria, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT with or without radiosensitive therapy and Radiosensitive therapy in people with Recurrent High Grade Glioma, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free of participants (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567539, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.