Status:
COMPLETED
Maintenance Therapy for Small-cell Lung Cancer
Lead Sponsor:
Qingdao Central Hospital
Conditions:
Progression Free Survival
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
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 radiotherap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03769935
Start Date
January 1 2017
End Date
July 1 2022
Last Update
March 29 2023
Active Locations (1)
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1
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China, 266042