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

NCT04536649 | Unknown Phase 3 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2020-45
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Glioblastoma

Keywords

Glioblastoma; Carbon-ion Radiotherapy; Proton Radiotherapy; Photon Radiotherapy; Overall Survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The interval from randomization to death

  From the pathological confirmation to death, a median of 3 years.

Secondary Outcomes (4)

• Progression-free Survival

  From randomization to tumor progression, with a median of 3 years.

• Toxicities

  From start to 12 months after completion of radiotherapy.

• Recognitive Function

  From initiation of radiotherapy to 12 months after completion of radiotherapy.

• Life Quality

  From initiation of radiotherapy to 12 months after completion of radiotherapy.

Study Arms (3)

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)

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).

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).

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Multimodal brain imaging-guided radiotherapy using different beams

Standard-dose Photon Radiotherapy; Standard-dose Proton Radiotherapy; Standard-dose Proton Radiotherapy plus Carbon-Ion Boost

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead
• RenJi Hospital: collaborator
• Ruijin Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jiade J Lu

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiade J Lu, M.D.

CONTACT

021-38296516; jiade.lu@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 2, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2025
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: On March, 2026
• Access Criteria: Excel document as the repository will be used for management.

Locations

CN (1)