An interventional study of Iodine-125+Chemotherapy and Surgical resection+Radiochemotherapy in Glioblastoma, sponsored by The Affiliated Hospital of Qingdao University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-29.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
The primary efficacy outcome was evaluated with progression-free survival (PFS).
1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's planned enrollment of 84 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Iodine-125; Temozolomide
Other: Iodine-125+Chemotherapy
Surgical resection; Radiotherapy; Temozolomide:
Other: Surgical resection+Radiochemotherapy
Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
Also known as: Iodine-125+Temozolomide
Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection. Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
Also known as: Surgical resection+Radiotherapy+Temozolomide
Progression-free survival (PFS)
PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated.
Time frame: 2.5 years after randomization
Overall Survival (OS)
OS is defined as the time from randomization to death from any causes.
Time frame: 2.5 years after randomization
Survival rates at 6 months and 1 year
The survival rates were measured at 6 months and 1 year
Time frame: at 6 months and 1 year after operation respectively
EORTC QLQ-C30
The Quality of life is measured with EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.
Time frame: 2.5 year after randomization
ECOG Performance Status
ECOG PS (Eastern Cooperative Oncology Group, performance status) is to assess how a patient's disease is progressing, and how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale is from 0 to 5. Higher scores mean a worse outcome.
Time frame: 2.5 year after randomization
Complications
Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on.
Time frame: within 1 week after operation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University