Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection

Summary

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.

Conditions

• Meningioma Atypical
• Radiotherapy
• Progression-Free Survival
• Adverse Effect of Radiation Therapy

Interventions

RADIATION

radiotherapy

Radiotherapy would start within 2 months after the operation, and 5 days of radiotherapy is performed every week. The dose of each radiotherapy is 1.8 Gy for 6 weeks, and the total dose is 54 Gy.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Jinhua Central Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Shaoxing Hospital of Zhejiang University

  collaborator OTHER

• People's Hospital of Quzhou

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2028-01-01

Completion

2033-01-01