The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Location status: Recruiting
NCT Number: NCT06740955
This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma.
A total of 420 subjects were enrolled in this study, randomized 1:1. According to the changes in overall survival time after postoperative concurrent chemoradiotherapy with different radiation doses, the stratification factors included the extent of surgical resection (total resection vs subtotal resection); The time of postoperative concurrent chemoradiotherapy (less than 28 days or more than 28 days); MGMT promoter methylation expression (positive or negative).
The study design was as follows: Participants were required to undergo a screening period within 14 days before randomization to determine eligibility. Subjects who met the inclusion criteria were randomly divided into two groups at a 1:1 ratio: trial group, hypofractionated concurrent chemoradiotherapy followed by at least 6 cycles of adjuvant temozolomide; The control group was treated with the existing standardized treatment (standard dose of concurrent chemoradiotherapy and at least 6 cycles of temozolomide adjuvant chemotherapy).
Experimental group: subjects randomly assigned to the experimental group were required to start treatment within 7 working days. The experimental group received hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, and temozolomide was given for 21 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. If there were residual lesions after surgery, measurable lesions were evaluated according to RANO standard case criteria.
Control group: subjects randomly assigned to the experimental group were treated within 7 working days. The control group received conventional fractionated radiotherapy with a dose of 60Gy, 2Gy per fraction, 30 fractions, 5 fractions per week, and temozolomide was given for a total of 42 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. Measurable lesions assessed according to RANO criteria were required if residual lesions were present after surgery.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Changchun, Jilin, 130021, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week,
Conventionally fractionated radiotherapy with a total dose of 60 Gy, 2 Gy/ fraction, 30 fractions, 5 fractions per week,
Time frame: 18 months
It was defined as the time between the start of the randomization date and the death of the subject due to various causes.
Time frame: 12 months
The experimental and control groups were defined as the time from randomization to tumor progression (according to RANO criteria) or death from any cause, whichever occurred first.
Time frame: 12 months
Interval between the date of randomization and the occurrence of radiographic progression according to RANO criteria.
Contact information is provided by the study sponsor or research team.
The First Hospital of Jilin University
Other
A Randomized, Open, Controlled, Multi-center Clinical Trial of Hypofractionated Postoperative Radiotherapy for Adult Glioblastoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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