Proton and heavy ion beam radiation versus photon beam radiation for newly-diagnosed glioblastoma: a multi-center prospective phase ? randomized control clinical trial.

Proton and heavy ion beam radiation versus photon beam radiation for newly-diagnosed glioblastoma: a multi-center prospective phase III randomized control clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036424

Enrollment

Unknown

Registered

2020-08-23

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

newly-diagnosed glioblastoma

Interventions

Control group :Standard photon radiation (60Gy)

Study group 1:Standard dose proton radiation (60GyE)

Study group 2:Standard dose proton radiation (60GyE) plus Carbon ion boost

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; 2. Pathologically confirmed newly-diagnosed GBM; 3. Redisual lesion after subtotal resection, partial resection, or biopsy; 4. No dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion; 5. ECOG score 0-1, without severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease and other complications that may affect the progress of radiotherapy; 6. Routine examination of peripheral blood before treatment meets the following conditions: neutrophil count>2000/mm3, platelet count>100,000/mm3; 7. Before treatment, liver and kidney function tests meet the following conditions: bilirubin 60 ml/min; 8. Sign the informed consent form before starting the research.

Exclusion criteria

Exclusion criteria: 1. No pathological confirmed evidence of GBM; 2. Multiple lesions or distant spread indicated by imaging studies; 3. Receive conventional photon/proton/carbon ion radiation therapy on the head; 4. Received intracranial radioactive particle implantation; 5. A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma); 6. Positive pregnancy test for women of childbearing age; 7. With the accompanying diseases or conditions affect the safety of patients during normal enrollment or research; 8. Active mental disorders or other mental disorders that affect the patients ability to sign informed consent and understand; 9. Uncontrolled active infection.

Design outcomes

Primary

Measure	Time frame
One-year overall survival rate;	—

Secondary

Measure	Time frame
Progression-free survival;side-effect;Quality of Life;	—

Countries

China

Contacts

Public ContactLin Kong, Jiade J Lu

Shanghai Proton and Heavy Ion Center

lin.kong@sphic.org.cn+86 021-38296666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026