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

Shanghai Proton and Heavy Ion Center

Status and phase: Not yet enrolling; Phase 3

Conditions: Glioblastoma

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04536649

SPHIC-TR-HNCNS-2020-45

Details and patient eligibility

About

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).

Full 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.

Enrollment: 369 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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369 participants in 3 patient groups

Standard-dose Photon Radiotherapy

Experimental group

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)

Treatment:

Radiation: Radiotherapy

Standard-dose Proton Radiotherapy

Experimental group

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).

Treatment:

Radiation: Radiotherapy

Standard-dose Proton Radiotherapy plus Carbon-Ion Boost

Experimental group

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).

Treatment:

Radiation: Radiotherapy