Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03388372|
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Nimotuzumab Drug: Temozolomide Radiation: Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma|
|Actual Study Start Date :||August 18, 2010|
|Actual Primary Completion Date :||March 23, 2017|
|Actual Study Completion Date :||March 23, 2017|
Experimental: Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.
Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.
Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.
- Progression-free survival (PFS) [ Time Frame: 2 years ]PFS will be calculated as the time from surgery to the date of progression-free.
- Overall survival (OS) [ Time Frame: 2 years ]OS will be calculated as the time from surgery to the date of death.
- Objective Response Rate (ORR) [ Time Frame: 6 months ]ORR: overall response rate (ORR), subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
- Incidence of adverse events [ Time Frame: 6 months ]Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388372
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Guangdong Brain Hospital|
|The First Affiliated Hospital/School of Clinical Medicine of Guangdong|
|The First Affiliated Hospital of Guangzhou Medical University|
|Shenzhen People's Hospital|
|Principal Investigator:||Shao-Xiong Wu, Professor||Sun Yat-sen University|