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

• Sponsor: Shanghai Proton and Heavy Ion Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04536649
• Collaborator: RenJi Hospital (Other), Ruijin Hospital (Other), Fudan University (Other)
• Enrollment: 369
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 6.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Radiation: Radiotherapy	Phase 3

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

• Study Type: Interventional
• Anticipated Enrollment: 369 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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)	Radiation: Radiotherapy; Multimodal brain imaging-guided radiotherapy using different beams
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).	Radiation: Radiotherapy; Multimodal brain imaging-guided radiotherapy using different beams
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).	Radiation: Radiotherapy; Multimodal brain imaging-guided radiotherapy using different beams

Outcome Measures

Primary Outcome Measures

1. Overall Survival [From the pathological confirmation to death, a median of 3 years.]

   The interval from randomization to death

Secondary Outcome Measures

1. Progression-free Survival [From randomization to tumor progression, with a median of 3 years.]

   The interval from randomization to progression or death

2. Toxicities [From start to 12 months after completion of radiotherapy.]

   The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events.

3. Recognitive Function [From initiation of radiotherapy to 12 months after completion of radiotherapy.]

   The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination.

4. Life Quality [From initiation of radiotherapy to 12 months after completion of radiotherapy.]

   The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai	China	201321

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jiade J Lu, Shanghai Proton and Heavy Ion Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiade J. Lu, Professor, Shanghai Proton and Heavy Ion Center
• ClinicalTrials.gov Identifier: NCT04536649
• Other Study ID Numbers: SPHIC-TR-HNCNS-2020-45
• First Posted: Sep 2, 2020
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiade J. Lu, Professor, Shanghai Proton and Heavy Ion Center: Glioblastoma; Carbon-ion Radiotherapy; Proton Radiotherapy; Photon Radiotherapy; Overall Survival
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Sep 2, 2020