Radiotherapy Clinical Trial
Official title:
A Multicenter Randomized Controlled Trial of the Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection
Postoperative adjuvant radiotherapy is a key component of comprehensive treatment of
meningioma. However, for atypical meningioma after total resection, there is still a huge
controversy in patients who need adjuvant radiotherapy after surgery.
Many scholars have focused on this problem and carried out some small-scale retrospective
studies, but they have contradictory results. Some of the studies found that postoperative
adjuvant radiotherapy could not improve the prognosis of patients, but was questioned because
the sample size was too small, resulting in insignificant results, while other studies found
that postoperative adjuvant radiotherapy can improve progression free survival. A study based
on the National Cancer Database found that postoperative adjuvant radiotherapy and gross
tumor resection are associated with a good prognosis. A recent meta-analysis enrolled a total
of 757 patients and found that postoperative adjuvant radiotherapy reduced the risk of tumor
recurrence but did not improve survival time. Our team reviewed the meningioma data in the
SEER database and conducted a study previously. The study found that postoperative adjuvant
radiotherapy did not improve the overall survival of these patients. The relevant research
results were recently published in Frontiers in oncology. We further reviewed and summarized
the single-center data of our hospital and found that postoperative adjuvant radiotherapy
could not improve the progression free survival and overall survival of patients. Besides, we
also performed a meta-analysis and found that postoperative adjuvant radiotherapy had a trend
to improve progression-free survival, but there was no statistical difference.
Because there are many deficiencies in previous researches, and the research results are also
contradictory, it is still unclear whether patients with atypical meningioma who have
undergone gross total resection can benefit from postoperative adjuvant radiotherapy. Further
high quality clinical trials is still needed to be conducted in order to guide the
postoperative care of patients. Therefore, we intend to conduct this multicenter randomized
controlled trial to determine the value of postoperative adjuvant radiotherapy in patients
with atypical meningioma who underwent gross total resection.
The study aims to enroll a total of 140 participants. Subjects would be enrolled with the
following information: name, age, gender, contact, KPS score, preoperative ASA score, current
ECOG score, tumor location, date of surgery, degree of tumor resection (modified Simpson
grade), pathology type, Ki-67 Proliferation index, etc. The preoperative magnetic resonance
image of the subject is stored. Tissue specimens are genetically examined.
Using a simple randomization method and random assignment in a 1:1 ratio, a random sequence
was first generated, and SAS version 9.1 statistical software was used to generate an
allocation sequence table including subject numbers, 140 random numbers, and random
groupings. 140 Subjects would be assigned to the test group (n=70) and the control group
(n=70) in a 1:1 ratio. The table of the assignment sequence is duplicated and saved by the
neurosurgical secretary and the trial designer of the Second Affiliated Hospital of Zhejiang
University. The secretary puts the group mark into the 140 opaque kraft envelopes with the
serial number 1 to 140 according to the order of the allocation sequence table, and submits
them to the test designer. Zhige Guo is responsible for enrolling the participants according
to the inclusion criteria, assigning the subjects numbers according to the order of the
treatment, and Qiang Zeng is responsible for disassembling the corresponding opaque envelopes
according to the number of the subjects, and exerting interventions according to the group
marks. Chenhan Ling is responsible for follow-up and regular measurement of various
indicators, and Fei Dong is responsible for the images reports. Until the end of the trial,
Zhige Guo, Chenhan Ling and Fei Dong would not know the grouping of the subjects.
The test level of the study was α=0.05, and the two-sided test was used. All statistical
analysis was performed by SPSS 16.0 statistical software.
1. For PFS, OS, and DSS data, the COX proportional hazards model was used to calculate the
hazard ratio (HR) of radiotherapy and to assess the statistical difference between the
corresponding prognostic data between the two groups.
2. For the 3-year progression-free survival, 3-year survival rate, and 5-year
progression-free survival, 5-year survival rate data, the chi-square test was used to
compare the differences between the two groups.
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