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

Primary Purpose

Glioblastoma

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Carbon-ion Radiotherapy, Proton Radiotherapy, Photon Radiotherapy, Overall Survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Proton and Heavy Ion Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard-dose Photon Radiotherapy

Standard-dose Proton Radiotherapy

Standard-dose Proton Radiotherapy plus Carbon-Ion Boost

Arm Description

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)

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).

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).

Outcomes

Primary Outcome Measures

Overall Survival
The interval from randomization to death

Secondary Outcome Measures

Progression-free Survival
The interval from randomization to progression or death
Toxicities
The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events.
Recognitive Function
The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination.
Life Quality
The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living.

Full Information

First Posted
August 25, 2020
Last Updated
August 28, 2020
Sponsor
Shanghai Proton and Heavy Ion Center
Collaborators
RenJi Hospital, Ruijin Hospital, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04536649
Brief Title
Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center
Collaborators
RenJi Hospital, Ruijin Hospital, Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Carbon-ion Radiotherapy, Proton Radiotherapy, Photon Radiotherapy, Overall Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard-dose Photon Radiotherapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Standard-dose Proton Radiotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard-dose Proton Radiotherapy plus Carbon-Ion Boost
Arm Type
Experimental
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Multimodal brain imaging-guided radiotherapy using different beams
Primary Outcome Measure Information:
Title
Overall Survival
Description
The interval from randomization to death
Time Frame
From the pathological confirmation to death, a median of 3 years.
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
The interval from randomization to progression or death
Time Frame
From randomization to tumor progression, with a median of 3 years.
Title
Toxicities
Description
The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events.
Time Frame
From start to 12 months after completion of radiotherapy.
Title
Recognitive Function
Description
The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination.
Time Frame
From initiation of radiotherapy to 12 months after completion of radiotherapy.
Title
Life Quality
Description
The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living.
Time Frame
From initiation of radiotherapy to 12 months after completion of radiotherapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiade J Lu, M.D.
Phone
021-38296516
Ext
86
Email
jiade.lu@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiade J Lu
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be uploaded by excel documents to share the IPD.
IPD Sharing Time Frame
On March, 2026
IPD Sharing Access Criteria
Excel document as the repository will be used for management.

Learn more about this trial

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

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