Refractory pituitary adenoma
Conditions
Interventions
A:Carbon Ion Radiation (60GyE/20Fx)
B:Proton Radiation (60GyE/30Fx)
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Histologically confirmed pituitary adenoma; 3. High risk of refractory tumor: (1) Aggressive growth of tumor after one or more operation, and difficult to be completeby removed with re-resection; (2) Rapid growth (tumor volume increassion more than 5% in 3-6 months); (3) For the first treatment, the tumor showed aggressive growth and large size, Ki67 above 3%; (4) Pathology included one of five types of "high-risk pituitary adenomas" : sparsely granular growth hormone cell adenomas, male prolactin cell adenomas, polyhormone Pit-1 positive adenomas, silent ACTH cell adenomas, and Crooke cell adenomas. 4. Residual lesion detected in imaging studies; 5. No distant and/or spinal metastasis; 6. Karnofsky Performance Score >=60; 7. Written informed consent (made available with required signature prior to enrollment on trial and initiation of treatment).
Exclusion criteria
Exclusion criteria: 1. Completely resection of pituitary lesion; 2. Distant metastatis; 3. Prior treatment with interstitial radioactive seeds; 4. Known carcinoma (excluding basal cell carcinoma,squamous cell carcinoma of the skin); 5. Pregnant or lactating women; 6. Inability of subject to understand character and individual consequences of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Side Effect; | — |
Countries
China
Contacts
Public ContactLin Kong
Shanghai Proton and Heavy Ion Center
Outcome results
None listed