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

NCT04127760 | Not Yet Recruiting DMC

• 1 other identifier: ns20191111
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Meningioma Atypical; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  the length of time during and after medication or treatment during which the disease being treated does not get worse

  60months

Secondary Outcomes (7)

• 3-year survival rate

  36months

• 3-year progression-free survival

  36months

• 5-year survival rate

  60months

• 10-year progression-free survival

  120 months

• 10-year survival rate

  120 months

Study Arms (2)

control

NO INTERVENTION

Follow-up at several time frames

treatment

EXPERIMENTAL

Radiotherapy would be carried out. Follow-up at the same time frames as the control arm

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

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.

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent gross total resection at each center and were diagnosed as atypical meningioma (WHO class II) according to the WHO 2016 diagnostic criteria.
• Gross total resection was defined as modified Simpson 1-3 and confirmed by postoperative magnetic resonance imaging.

You may not qualify if:

• age less than 18 years old or older than 70 years
• meningioma recurrence
• patients had previous radiotherapy
• multiple meningioma
• optic nerve sheath meningioma or other extracranial meningioma
• tumor involving venous sinus
• ECOG score ≥ 2 points
• preoperative ASA grade ≥ 3
• previous or current malignant tumors
• pregnant or lactating women
• Patients with Gd-DTPA allergies, spatial claustrophobia or pacemaker implantation that can not be conducted constract-enhanced head magnetic resonance examination
• patients who were unable to obtain informed consent or refused to participate in the study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Jinhua Central Hospital: collaborator
• Taizhou Hospital: collaborator
• Shaoxing Hospital of Zhejiang University: collaborator
• People's Hospital of Quzhou: collaborator
• Huzhou Central Hospital: collaborator

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Qiang Zeng, MD

CONTACT

+86 0571 87784715; zengqiang@zju.edu.cn

Jianmin Zhang, MD, PhD

CONTACT

+86 0571 87784715; zjm135@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2033
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share