A Phase 2 interventional study of TMZ and WBRT with avoidance of hippocampus in Brain Metastasis and Radiation Therapy Complication, sponsored by Sun Yat-sen University. Status unknown at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-14.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.
This is a phase II randomized clinical trial. It is reported that avoidance of hippocampus during whole-brain radiotherapy (WBRT) had benefits in preservation of memory for patients, and the use of concurrent TMZ in radiotherapy for patients with brain metastases benefited for treating outcome.
The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 256 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
Radiation: WBRT without avoidance of hippocampus
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
Radiation: WBRT with avoidance of hippocampus
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
Drug: TMZ · Radiation: WBRT without avoidance of hippocampus
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
Drug: TMZ · Radiation: WBRT with avoidance of hippocampus
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
Also known as: temozolomide
Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
Change of neurocognitive function between baseline and 4 months after radiotherapy
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
Time frame: baseline; four months after radiotherapy
Effect on response rate
Response is evaluated on basis of RECIST
Time frame: baseline; One, two, four, six, and twelve months after radiotherapy
The tolerance of radiotherapy with TMZ concurrent chemotherapy
Adverse effects are evaluated by CTCAE 4.0 criteria
Time frame: baseline; once a week through during radiotherapy, up to 3 weeks
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University