skull base chordoma
Conditions
Interventions
Proton Radiation Combined with PARP Inhibitors Treatment Group:Proton Radiation Combined with PARP Inhibitors
Proton Radiation Group:Intensity modulated proton therapy,IMPT
Sponsors
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years; 2.Histologically confirmed classic or chondroid skull base chordoma; 3.Status after subtotal resection or biopsy with radiologically confirmed residual tumor, or recurrent disease after prior surgery in patients refusing reoperation; 4.No prior radiotherapy; 5.Life expectancy >=6 months; 6.ECOG performance status 0–1, without severe comorbidities (e.g., pulmonary hypertension, cardiovascular disease, peripheral vascular disease, or advanced chronic cardiac disease) that may compromise radiotherapy delivery; 7.Pre-treatment hematologic criteria: Absolute neutrophil count (ANC) >2000/mm^3 Platelet count >100,000/mm^3 8. Pre-treatment hepatic/renal function criteria: Total bilirubin 60 mL/min (calculated by Cockcroft-Gault); 8.Signed informed consent before study enrollment.
Exclusion criteria
Exclusion criteria: 1.No histopathological confirmation of classic or chondroid skull base chordoma; 2.Status after gross total resection (GTR) with no radiologically detectable residual tumor; 3.Evidence of distant metastasis on imaging; 4.Prior radioactive seed implantation in the treatment area; 5.History of other malignancies or synchronous multiple primary tumors (except basal cell carcinoma of the skin); 6.Positive pregnancy test in women of childbearing potential; 7.Concurrent medical conditions that compromise patient eligibility or safety during the study; 8.Active psychiatric disorders or other cognitive impairments affecting informed consent comprehension; 9.Uncontrolled active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 year Local progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicity;5 year overall survival; | — |
Countries
China
Contacts
Public ContactQingting Huang
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed