Back to resultsMaintenance Therapy for Small-cell Lung Cancer
Primary Purpose
Progression Free Survival
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cis Platinum, etoposide, S1
Sponsored by
About this trial
This is an interventional treatment trial for Progression Free Survival
Eligibility Criteria
Inclusion Criteria:
- 1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets
Exclusion Criteria:
- 1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.
Sites / Locations
- Qingdao Central Hospital, Qingdao Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental arm
active comparator
Arm Description
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
Outcomes
Primary Outcome Measures
The progression-free survival in this population of patients
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
Secondary Outcome Measures
Percentage of Participants Experiencing an Adverse Event (AE)
Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
The overall survival in this population of patients.
The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1
Full Information
NCT ID
NCT03769935
First Posted
December 6, 2018
Last Updated
March 27, 2023
Sponsor
Qingdao Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03769935
Brief Title
Maintenance Therapy for Small-cell Lung Cancer
Official Title
Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qingdao Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
Detailed Description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression Free Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
Arm Title
active comparator
Arm Type
Active Comparator
Arm Description
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
Intervention Type
Drug
Intervention Name(s)
cis Platinum, etoposide, S1
Intervention Description
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
Primary Outcome Measure Information:
Title
The progression-free survival in this population of patients
Description
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing an Adverse Event (AE)
Description
Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Time Frame
2.5 years
Title
The overall survival in this population of patients.
Description
The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets
Exclusion Criteria:
1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.
Facility Information:
Facility Name
Qingdao Central Hospital, Qingdao Cancer Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
12. IPD Sharing Statement
Learn more about this trial
Maintenance Therapy for Small-cell Lung Cancer
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