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

Glioblastoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04536649
• Other study ID #: SPHIC-TR-HNCNS-2020-45
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2020
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Jiade J Lu, M.D.
• Phone: 021-38296516
• Email: jiade.lu[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 369
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• Radiotherapy
Multimodal brain imaging-guided radiotherapy using different beams

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center	Fudan University, RenJi Hospital, Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The interval from randomization to death	From the pathological confirmation to death, a median of 3 years.
Secondary	Progression-free Survival	The interval from randomization to progression or death	From randomization to tumor progression, with a median of 3 years.
Secondary	Toxicities	The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events.	From start to 12 months after completion of radiotherapy.
Secondary	Recognitive Function	The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination.	From initiation of radiotherapy to 12 months after completion of radiotherapy.
Secondary	Life Quality	The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living.	From initiation of radiotherapy to 12 months after completion of radiotherapy.