Invasive pituitary adenoma
Conditions
Interventions
Treatment Group:Preoperative stereotactic radiotherapy with Cyberknife
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old = 75 years old, regardless of gender; (2) Pathologically confirmed as pituitary adenoma (recurrence patients who have undergone surgery and pathology confirmed; initial treatment patients need to undergo sphenoid sinus biopsy and pathology confirmed); (3) The lesion is limited to the anterior and middle skull base (ethmoid sinus, sphenoid sinus, cavernous sinus, pterygomandibular fossa, etc.), without obvious visual pathway compression or intracranial invasion. The maximum diameter of the lesion is greater than or equal to 3cm, and according to imaging evaluation, surgery is temporarily unable to completely remove it (4) Has not undergone radiation therapy in the past; (5) Expected survival time = 6 months; (6) KPS score = 70; (7) Able to read, understand, and sign a written informed consent form before participating in the study, and willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Within one month prior to screening, the subject had participated in other clinical studies; (2) Diagnosed as pituitary adenocarcinoma or combined with other malignant tumors; (3) Patients with severe acute and chronic diseases of various systems that have not been effectively controlled or have unstable conditions, including but not limited to: heart failure (NYHA heart function grading = 2), uncontrolled cardiomyopathy, coronary heart disease, severe arrhythmia and other serious heart disease patients; Severe active infection; Uncontrollable diabetes, hypertension/hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc; Any other medical history of diseases judged by the researcher as unsuitable for participation in this trial; (4) For patients with liver and kidney dysfunction, total bilirubin>1.5 × ULN, ALT and AST>2.5 × ULN; Blood creatinine>2 x ULN; (5) Neutrophil count<1.5 × 10^9/L, platelet count<100 × 10^9/L, or HGB<90g/L; (6) Pregnant, lactating women or those who are unwilling to use contraception during the trial period; (7) Researchers believe that there are other factors that are not suitable for participating in the experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total tumor resection rate ;The incidence of surgical complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor resection rate;Disease progression free survival; | — |
Countries
China
Contacts
Public ContactYao Zhao
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed