GlioblastomaPhase 3NCT04536649
Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
A Phase 3 study testing Radiotherapy in people with Glioblastoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
This is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2025
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old and <80 years old
- Pathologically confirmed newly-diagnosed GBM
- Redisual lesion after subtotal resection, partial resection, or biopsy
- No dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion
- ECOG score 0-1
- Sign the informed consent form before starting the research
Who cannot join
- No pathological confirmed evidence of GBM
- Multiple lesions or distant spread indicated by imaging studies
- Receive conventional photon/proton/carbon ion radiation therapy on the head
- Received intracranial radioactive particle implantation
- A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma)
- Positive pregnancy test for women of childbearing age
Show all 9Show fewer
- With the accompanying diseases or conditions affect the safety of patients during normal enrollment or research
- Active mental disorders or other mental disorders that affect the patients ability to sign informed consent and understand
- Uncontrolled active infection
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201321
About this study
Official title: Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
This is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. The patients enrolled will be randomly allocated with 1:1:1 to three group: Control Group, standard-dose photon radiotherapy; Study Group A, standard-dose proton radiotherapy; Study Group B, standard-dose proton radiotherapy plus induction carbon-ion radiotherapy boost. The primary endpoint is overall survival (OS).
Read the detailed description
This multi-center prospective phase 3 clinical trial will enroll 369 patients with newly diagnosed glioblastoma. Patients will be randomly allocated with 1:1:1 to three groups: Control Group, standard-dose photon radiotherapy (60 Gy); Study Group A, standard-dose proton radiotherapy (60 GyE); Study Group B, standard-dose proton radiotherapy (60 GyE) plus induction carbon-ion radiotherapy boost (15GyE/3F). All patients will receive concurrent and adjuvant temozolomide according to the Stupp protocol. The primary endpoint is overall survival (OS). The secondary endpoint is progression-free survival, side effect and quality life.
- Conditions
- Glioblastoma
- Being tested
- Radiotherapy
- Keywords
- Glioblastoma, Carbon-ion Radiotherapy, Proton Radiotherapy, Photon Radiotherapy, Overall Survival
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Multimodal brain imaging-guided radiotherapy using different beams
| Study group | Role | What they receive |
|---|---|---|
| Standard-dose Photon Radiotherapy | Experimental | The patients will receive standard-dose photon radiation (60Gy/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle) Receives: Radiation: Radiotherapy |
| Standard-dose Proton Radiotherapy | Experimental | The patients will receive standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). Receives: Radiation: Radiotherapy |
| Standard-dose Proton Radiotherapy plus Carbon-Ion Boost | Experimental | The patients will receive carbon-ion radiation boost (15GyE/3F for residual lesion) priot to standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), then adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The interval from randomization to death
Measured: From the pathological confirmation to death, a median of 3 years.
Secondary outcomes (4)
Progression-free Survival
The interval from randomization to progression or death
Measured: From randomization to tumor progression, with a median of 3 years.
Toxicities
The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events.
Measured: From start to 12 months after completion of radiotherapy.
Recognitive Function
The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination.
Measured: From initiation of radiotherapy to 12 months after completion of radiotherapy.
Life Quality
The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living.
Measured: From initiation of radiotherapy to 12 months after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, Fudan University
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536649
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2020-45
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be uploaded by excel documents to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
- ClinicalTrials.gov ID
- NCT04536649
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2020-45
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Carbon-ion Radiotherapy, Proton Radiotherapy, Photon Radiotherapy, Overall Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, Fudan University
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Sep 2020 (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.
This is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. The patients enrolled will be randomly allocated with 1:1:1 to three group: Control Group, standard-dose photon radiotherapy; Study Group A, standard-dose proton radiotherapy; Study Group B, standard-dose proton radiotherapy plus induction carbon-ion radiotherapy boost. The primary endpoint is overall survival (OS).
Detailed description
This multi-center prospective phase 3 clinical trial will enroll 369 patients with newly diagnosed glioblastoma. Patients will be randomly allocated with 1:1:1 to three groups: Control Group, standard-dose photon radiotherapy (60 Gy); Study Group A, standard-dose proton radiotherapy (60 GyE); Study Group B, standard-dose proton radiotherapy (60 GyE) plus induction carbon-ion radiotherapy boost (15GyE/3F). All patients will receive concurrent and adjuvant temozolomide according to the Stupp protocol. The primary endpoint is overall survival (OS). The secondary endpoint is progression-free survival, side effect and quality life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard-dose Photon Radiotherapy | Experimental | Radiation: RadiotherapyThe patients will receive standard-dose photon radiation (60Gy/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle) |
| Standard-dose Proton Radiotherapy | Experimental | Radiation: RadiotherapyThe patients will receive standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). |
| Standard-dose Proton Radiotherapy plus Carbon-Ion Boost | Experimental | Radiation: RadiotherapyThe patients will receive carbon-ion radiation boost (15GyE/3F for residual lesion) priot to standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), then adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age> 18 years old and <80 years old
- Pathologically confirmed newly-diagnosed GBM
- Redisual lesion after subtotal resection, partial resection, or biopsy
- No dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion
- ECOG score 0-1
Key exclusion criteria (9 listed)
- No pathological confirmed evidence of GBM
- Multiple lesions or distant spread indicated by imaging studies
- Receive conventional photon/proton/carbon ion radiation therapy on the head
- Received intracranial radioactive particle implantation
- A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma)
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 |
|---|---|---|
| RadiotherapyMultimodal brain imaging-guided radiotherapy using different beams | Radiation | Standard-dose Photon Radiotherapy, Standard-dose Proton Radiotherapy, Standard-dose Proton Radiotherapy plus Carbon-Ion Boost |
Primary outcome
Overall Survival
Time frame: From the pathological confirmation to death, a median of 3 years.
The interval from randomization to death
4 secondary outcomes
Progression-free Survival
Time frame: From randomization to tumor progression, with a median of 3 years.
Toxicities
Time frame: From start to 12 months after completion of radiotherapy.
Recognitive Function
Time frame: From initiation of radiotherapy to 12 months after completion of radiotherapy.
Life Quality
Time frame: From initiation of radiotherapy to 12 months after completion of radiotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Yes. The data will be uploaded by excel documents to share the IPD.
Related trials for Glioblastoma
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.
Jiade J Lu principal investigator
Shanghai Proton and Heavy Ion Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy in people with Glioblastoma, run by Shanghai Proton and Heavy Ion Center 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 6 inclusion and 9 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 2 Sep 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jiade J Lu, M.D. (021-38296516 ext. 86, jiade.lu@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From the pathological confirmation to death, a median of 3 years.). 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 2 Sep 2020.