PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
NCT ID: NCT04535739
Last Updated: 2020-09-02
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
PHASE3
414 participants
INTERVENTIONAL
2019-07-01
2022-06-30
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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PCI group
patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy and prophylactic cranial irradiation。
prophylactic cranial irradiation
25Gy/2.5Gy/10f were given for PCI patients
control group
patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy。
prophylactic cranial irradiation
25Gy/2.5Gy/10f were given for PCI patients
Interventions
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prophylactic cranial irradiation
25Gy/2.5Gy/10f were given for PCI patients
Eligibility Criteria
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Inclusion Criteria
* Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
* 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
* CR or PR after chemotherapy；
* no grade ≥II side effects;
* the estimated overall survival time ≥ 3 months;
* no serious medical disease or major organ dysfunction.
Exclusion Criteria
* Presence of high grade radiation comorbidities;
* Patients who are pregnant or lactating
18 Years
65 Years
ALL
Yes
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Zongmei Zhou
clinical professor
Locations
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Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17-184/1440
Identifier Type: -
Identifier Source: org_study_id
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