- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535739
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
August 28, 2020 updated by: Zongmei Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
414
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zongmei zhou, master
- Phone Number: 86 13801389769
- Email: zhouzongmei2013@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- zongmei zhou, master
- Phone Number: 86 13801389769
- Email: zhouzongmei2013@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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。
|
25Gy/2.5Gy/10f were given for PCI patients
|
Other: 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。
|
25Gy/2.5Gy/10f were given for PCI patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2 year
|
rate of patients survival in 2 years
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: 2 year
|
the rate of patients survival from the treatment to death or progress
|
2 year
|
brain metastases rates
Time Frame: 2 year
|
Cumulative incidence of brain metastases over 2 year
|
2 year
|
side effect
Time Frame: 2 year
|
HLVT
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
January 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 2, 2020
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-184/1440
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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