Glioblastoma MultiformePhase 2NCT03212235
Hypofractionated Radiation Therapy for Glioblastoma
A Phase 2 study testing Hypofractionated radiation therapy in people with Glioblastoma Multiforme, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Hypofractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jun 2017to 1 Jun 2020
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
- WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.
Who cannot join
- Prior diagnosis of cancer, unless disease free for > 3 years
- Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
- Specific severe, active co-morbidities
- Tumor located in the brainstem
- Presence of leptomeningeal carcinomatosis
- Multicentric tumor
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP
São Paulo, São Paulo, 01246-000
Gustavo N Marta, PhD, 55+11+38934538, gustavo.marta@hc.fm.usp.br
About this study
Official title: Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Hypofractionated radiation therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiation therapyRadiation
Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiation therapy | Experimental | Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week.
After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles. Receives: Radiation: Hypofractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From date of the start of treatment to date of death due to any cause.
Measured: 24 months
Secondary outcomes (1)
Progression-free survival
The time between the start of treatment and tumor progression or death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start5 Jun 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Nader Marta, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212235
- Sponsor's protocol ID
- Hypofractionated GBM
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
- ClinicalTrials.gov ID
- NCT03212235
- Acronym / sponsor ID
- Hypofractionated GBM
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiation therapy | Experimental | Radiation: Hypofractionated radiation therapyHypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
- WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.
Key exclusion criteria (6 listed)
- Prior diagnosis of cancer, unless disease free for > 3 years
- Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
- Specific severe, active co-morbidities
- Tumor located in the brainstem
- Presence of leptomeningeal carcinomatosis
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 |
|---|---|---|
| Hypofractionated radiation therapyHypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) | Radiation | Hypofractionated radiation therapy |
Primary outcome
Overall survival
Time frame: 24 months
From date of the start of treatment to date of death due to any cause.
1 secondary outcome
Progression-free survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated radiation therapy in people with Glioblastoma Multiforme, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo N Marta, PhD (551138934538, gustavo.marta@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017.