Spots Global Cancer Trial Database for A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs
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Trial Identification
Brief Title: A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs
Official Title: A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, , Well Differentiated， Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours
Study ID: NCT05459844
Conditions
Study Description
Brief Summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium\[177Lu\] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Detailed Description: After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium\[177Lu\] Oxodotreotide Injection or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by primary site of tumor (pancreatic or non-pancreatic), NET pathological grading (G1 or G2) and by the length of time that a participant was on a constant dose of Octreotide (=\< 6 versus \> 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: any participants with progressive disease ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chinese PLA General Hospital, Beijing, Beijing, China
The First Afilliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Nanjing First Hospital, Nanjing, Jiangsu, China
The first hospital of Jilin University, Changchun, Jilin, China
The First Affiliated Hospital of AFMU, Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
The First Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
Mianyang Central Hospital, Mianyang, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Jianming Xu
Affiliation: Chinese PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR
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