Glioblastoma MultiformePhase 2NCT02663440
Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study testing Hypofractionated IMRT, Granulocyte-macrophage Colony-stimulating Factor and Temozolomide in people with Glioblastoma Multiforme, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Hypofractionated IMRT, Granulocyte-macrophage Colony-stimulating Factor and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging
- Karnofsky performance status more than 60
- Normal liver, kidney, and bone marrow function.
Who cannot join
- Previous allergies to granulocyte macrophage colony stimulating factor
- Receiving radiotherapy
- Receiving other investigational agents
- Had uncontrolled intercurrent illnesses.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, 86-571-88122098, cxzfyun@sina.com
Xiaozhong Chen, MD
About this study
Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Hypofractionated IMRT, Granulocyte-macrophage Colony-stimulating Factor, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated IMRTRadiation
Hypofractionated IMRT
Granulocyte-macrophage Colony-stimulating FactorBiological
Granulocyte-macrophage Colony-stimulating Factor
TemozolomideDrug
Temozolomide
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Experimental | Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor Receives: Radiation: Hypofractionated IMRT; Biological: Granulocyte-macrophage Colony-stimulating Factor; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663440
- Sponsor's protocol ID
- ZJZLYY-HN-2016-01
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 26 Jan 2016
- Results posted
- No
Publications
Cao C, Wang L, Jiang F, Jin Q, Jin T, Huang S, Hu Q, Chen Y, Piao Y, Hua Y, Feng X, Zhou Y, Chen X. Granulocyte-macrophage colony-stimulating factor for newly diagnosed glioblastoma. Neoplasia. 2025 May;63:101156. doi: 10.1016/j.neo.2025.101156. Epub 2025 Mar 15.
PubMed 40090128
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT02663440
- Acronym / sponsor ID
- ZJZLYY-HN-2016-01
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 26 Jan 2016 (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.
Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT | Experimental | Radiation: Hypofractionated IMRT, Biological: Granulocyte-macrophage Colony-stimulating Factor, Drug: TemozolomideHypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging
- Karnofsky performance status more than 60
- Normal liver, kidney, and bone marrow function.
Key exclusion criteria (4 listed)
- Previous allergies to granulocyte macrophage colony stimulating factor
- Receiving radiotherapy
- Receiving other investigational agents
- Had uncontrolled intercurrent illnesses.
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 IMRTHypofractionated IMRT | Radiation | IMRT |
| Granulocyte-macrophage Colony-stimulating FactorGranulocyte-macrophage Colony-stimulating Factor | Biological | IMRT |
| TemozolomideTemozolomide | Drug | IMRT |
Primary outcome
PFS
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 40090128Cao C, Wang L, Jiang F, Jin Q, Jin T, Huang S, Hu Q, Chen Y, Piao Y, Hua Y, Feng X, Zhou Y, Chen X. Granulocyte-macrophage colony-stimulating factor for newly diagnosed glioblastoma. Neoplasia. 2025 May;63:101156. doi: 10.1016/j.neo.2025.101156. Epub 2025 Mar 15.
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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 IMRT, Granulocyte-macrophage Colony-stimulating Factor and Temozolomide in people with Glioblastoma Multiforme, run by Zhejiang Cancer Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2016. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT02663440, which also lists 1 linked publication.
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 26 Jan 2016.