The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to determine whether radiotherapy combined with Temozolomide is
more effective than radiotherapy alone in the treatment of patients with refractory pituitary
adenomas. The Basic treatment was Radiotherapy over a period of six weeks, for a total dose
of 54 Gy. The150 participants were randomized to use either radiotherapy plus Temozolomide
(75 mg per square meter of body-surface area per day, 7 days per week from the first to the
last day of radiotherapy), or radiotherapy plus placebo for 6 weeks. After a 4-week break,
followed by six cycles of placebo or adjuvant temozolomide (150 to 200 mg per square meter
for 5 days during each 28-day cycle). The primary end point was Objective Response rate, the
second end point was PFS. Greater response was anticipated in patients treated with
Temozolomide+ radiotherapy than radiotherapy alone.