Back to resultsPCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
Primary Purpose
Small-cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
prophylactic cranial irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring small cell lung cancer, Brain Metastases
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old,KPS≥70
- 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:
- Patients with brain or nervous system metastases;
- Presence of high grade radiation comorbidities;
- Patients who are pregnant or lactating
Sites / Locations
- Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PCI group
control group
Arm Description
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。
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。
Outcomes
Primary Outcome Measures
overall survival
rate of patients survival in 2 years
Secondary Outcome Measures
progression-free survival
the rate of patients survival from the treatment to death or progress
brain metastases rates
Cumulative incidence of brain metastases over 2 year
side effect
HLVT
Full Information
NCT ID
NCT04535739
First Posted
August 28, 2020
Last Updated
August 28, 2020
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04535739
Brief Title
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
Official Title
A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
Keywords
small cell lung cancer, Brain Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCI group
Arm Type
Experimental
Arm Description
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。
Arm Title
control group
Arm Type
Other
Arm Description
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。
Intervention Type
Radiation
Intervention Name(s)
prophylactic cranial irradiation
Intervention Description
25Gy/2.5Gy/10f were given for PCI patients
Primary Outcome Measure Information:
Title
overall survival
Description
rate of patients survival in 2 years
Time Frame
2 year
Secondary Outcome Measure Information:
Title
progression-free survival
Description
the rate of patients survival from the treatment to death or progress
Time Frame
2 year
Title
brain metastases rates
Description
Cumulative incidence of brain metastases over 2 year
Time Frame
2 year
Title
side effect
Description
HLVT
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-65 years old,KPS≥70
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:
Patients with brain or nervous system metastases;
Presence of high grade radiation comorbidities;
Patients who are pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zongmei zhou, master
Phone
86 13801389769
Email
zhouzongmei2013@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
lei deng, dr
Phone
86 13683377570
Email
dengleipumc@163.com
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zongmei zhou, master
Phone
86 13801389769
Email
zhouzongmei2013@163.com
12. IPD Sharing Statement
Learn more about this trial
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
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