Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
NCT ID: NCT02605811
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
426 participants
INTERVENTIONAL
2015-09-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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temozolomide
temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
temozolomide
prophylaxis cranial radiotherapy
prophylaxis cranial radiotherapy,25-30Gy/10Fra
prophylaxis cranial radiotherapy
2
Interventions
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temozolomide
prophylaxis cranial radiotherapy
2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18 years or older
3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
4. Local stage SCLC without distant metastases
5. After 1st-line chemotherapy (EP or IP) at least 4 cycles
6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
7. CR or PR assessment by RECIST(1.0) before randomized
8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
9. Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion Criteria
2. Neck and supraclavicular lymph node metastasis
3. Be allergic to temozolomide or intolerable to radiotherapy
4. Any unstable systemic disease
5. Pregnant or lactating women
18 Years
75 Years
ALL
No
Sponsors
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Guangzhou Medical University
OTHER
Responsible Party
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Haihong Yang, MD, Pricipal investigator
Associate Chief Physician
Principal Investigators
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Hailing Yang, MD
Role: PRINCIPAL_INVESTIGATOR
the first affiliated hospital of Guangzhou MC
Locations
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The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Haihng Yang, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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GACA1501
Identifier Type: -
Identifier Source: org_study_id
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