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STUDY PROTOCOL
Year : 2022  |  Volume : 5  |  Issue : 2  |  Page : 69-76

Postoperative radiotherapy with concomitant temozolomide plus anlotinib for newly diagnosed glioblastoma: Study protocol for a multicenter, double-blind, randomized phase II trial


1 Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, Guangdong Province, China
2 Department of Radiation Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, China
3 Department of Radiation Oncology, Lanzhou University Second Hospital, Lanzhou, Gansu Province, China
4 Department of Neurosurgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China
5 Department of Neurosurgery, Internet Hospital of Tianjin Medical University General Hospital, Tianjin, China
6 Department of Neurosurgery, Chinese PLA General Hospital, Beijing, China
7 Department of Neurosurgery, Tangdu Hospital, Xi'an, Shaanxi Province, China
8 Department of Radiation Oncology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, Zhejiang Province, China
9 Department of Neurosurgery, Henan Cancer Hospital, Zhengzhou, Henan Province, China
10 Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
11 Department of Radiation Oncology, The First Hospital of Lanzhou University, Lanzhou, Gansu Province, China
12 Department of Neurosurgery, Gansu Provincial Hospital, Lanzhou, Gansu Province, China
13 Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
14 Department of Radiation Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province, China
15 Department of Neurosurgery, Chongqing University Cancer Hospital, Chongqing, China
16 Department of Radiation Oncology, Fujian Cancer Hospital, Fuzhou, Fujian Province, China
17 Department of Radiation Oncology, Shenzhen People's Hospital, Shenzhen, Guangdong Province, China
18 Department of Neurosurgery, The Sixth Medical Center of PLA General Hospital, Beijing, China
19 Department of Radiation Oncology, The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, Guangdong Province, China
20 Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
21 Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, Guangdong Province, China
22 Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, Guangdong Province, China

Correspondence Address:
Dr. Zhong-ping Chen
Department of Neurosurgery/Neuro-Oncology, Sun Yat-sen University Cancer Center, 651 East Dongfeng Road, Guangzhou 510060
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/glioma.glioma_17_22

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Background and Aim: Postoperative radiotherapy with concomitant temozolomide (TMZ) followed by ≤ six cycles of adjuvant TMZ chemotherapy (Stupp regimen) is the standard treatment for newly diagnosed glioblastoma (GBM); however, its effectiveness is limited. Anlotinib inhibits both tumor angiogenesis and tumor cell proliferation by targeting multiple kinases, and showing promising results in preclinical GBM models. We designed a Phase II trial to assess the efficacy and safety of the Stupp regimen plus anlotinib. Methods/Design: This is a multicenter, double-blind, randomized, placebo-controlled trial with an expected 150 patients randomly assigned 1:1 ratio to receive TMZ-based radiochemotherapy with anlotinib (Stupp regimen + anlotinib) or placebo (Stupp regimen + placebo). Postoperative patient recruitment will begin in July 2021, the analysis of primary outcome measures will be completed in July 2023, and the study will finish in July 2024. Major eligibility criteria include histologically confirmed newly diagnosed GBM and an Eastern Cooperative Oncology Group performance score ≤2. Other criteria for inclusion include age ≥18 years and lack of significant comorbidity. In this study, the primary endpoint will be the median progression-free survival (PFS). Secondary endpoints include 1-year overall survival rate, PFS at 6 months, overall response rate, duration of response, disease control rate, quality of life, and toxicity. The protocol has received approval from Sun Yat-sen University Cancer Center Ethics Committee (Approval No. B2021-073-01; approved on April 19, 2021). Discussion: Updated treatment modalities are required for newly diagnosed GBM. Our proposed treatment modality of the Stupp regimen combined with anlotinib therapy are waiting conclusion. Trial Registration: This study was registered with ClinicalTrials.gov under identifier NCT04959500 on July 13, 2021.


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