PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
1 other identifier
interventional
414
1 country
1
Brief Summary
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 2, 2020
October 1, 2019
2.6 years
August 28, 2020
August 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
rate of patients survival in 2 years
2 year
Secondary Outcomes (3)
progression-free survival
2 year
brain metastases rates
2 year
side effect
2 year
Study Arms (2)
PCI group
EXPERIMENTALpatients 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。
control group
OTHERpatients 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。
Interventions
25Gy/2.5Gy/10f were given for PCI patients
Eligibility Criteria
You may qualify if:
- years old,KPS≥70
- Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
- 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.
You may not qualify if:
- Patients with brain or nervous system metastases;
- Presence of high grade radiation comorbidities;
- Patients who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 2, 2020
Study Start
July 1, 2019
Primary Completion
January 30, 2022
Study Completion
June 30, 2022
Last Updated
September 2, 2020
Record last verified: 2019-10