High-grade glioma
Conditions
Interventions
Dose level 1:proton 60GyE/30F+ C-ion 6GyE/2F
Dose level 2:proton 60GyE/30F+ C-ion 9GyE/3F
Dose level 3:proton 60GyE/30F+ C-ion 12GyE/4F
????60 GyE/30F+???????15GyE/5F:proton 60GyE/30F+ C-ion 15GyE/5F
Group 5:proton 60GyE/30F+ C-ion 15GyE/6F
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, unifocal, supra-tentorial high-grade glioma, including AA, AOG, AOA, GBM; 2. Residual, clinically measurable tumor up to 5cm in largest dimension on post-resection MET/PET-MRS or MRI; 3. Indication for adjuvant radiotherapy with concurrent temozolomide administration; 4. Aged 18 to 65 years; 5. Karnofsky Performance Score =60; 6. Ability of the patient to understand the purpose of the clinical trial and possible consequences of their participation; 7. Written informed consent (made available with required signature prior to enrollment on trial and initiation of treatment).
Exclusion criteria
Exclusion criteria: 1. Patient refusal; 2. Previous radiotherapy to the brain; 3. Previous malignancy requiring cytotoxic therapy within 5 years prior to enrollment; 4. No residual, clinically measurable disease on post resection MET/PET-MRS or MRI; 5. A time interval >8 weeks between surgery and initiation on radiotherapy; 6. Patients who have not yet recovered from toxicities of prior treatments; 7. Pregnant or lactating women; 8. Participation in another clinical study or in an observation phase of a competing trial, respectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting adverse toxicity, DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Progression-free survival rate; | — |
Countries
China
Contacts
Public ContactJiade J Lu
Shanghai Proton and Heavy Ion Center
Outcome results
None listed