Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04536649
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Proton and Heavy Ion Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jiade J Lu
Principal Investigator Affiliation	Shanghai Proton and Heavy Ion Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Standard-dose Photon Radiotherapy

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)

Experimental: Standard-dose Proton Radiotherapy

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).

Experimental: Standard-dose Proton Radiotherapy plus Carbon-Ion Boost

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).

Interventions

Radiation: - Radiotherapy

Multimodal brain imaging-guided radiotherapy using different beams

Contact a Trial Team

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International Sites

Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, China

Status

Address

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai, 201321

Site Contact

[email protected]

021-38296516

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