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The main question it aims to answer are:
Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 ~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reduced CTV (clinical target volume) and PTV (planning target volume) | Experimental |
| |
| EORTC CTV (clinical target volume) and PTV (planning target volume) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced target volume | Radiation | Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV_6000. The clinical target volume_6000 cGy (CTV_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included. If CTV_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | confirm if the participant dies every time back to the hospital during screening and follow-up | From date of randomization until the date of death from any cause, assessed up to 3 year |
| European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujing Tan, Doctor | Contact | +8613560347303 | tanyujing-1981@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yujing Tan, Doctor | +8613560347303 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| southern medical university affiliated Zhujiang Hospital | Recruiting | Guangzhou | China |
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|
| EORTC (European organisation for research and treatment of cancer) target volume | Radiation | delineate according to EORTC guideline |
|
EORTC-QLQ-C30 questionnaire |
| through study completion, up to 3 years |
| radiotherapy complication incidence | through study completion, up to 3 years |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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