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Maintenance Therapy for Small-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03769935
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Qingdao Central Hospital

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.

Condition or disease Intervention/treatment Phase
Progression Free Survival Drug: cis Platinum, etoposide, S1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020


Arm Intervention/treatment
Experimental: experimental arm

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

Drug: cis Platinum, etoposide, S1

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


Active Comparator: active comparator
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
Drug: cis Platinum, etoposide, S1

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 Measures :
  1. The progression-free survival in this population of patients [ Time Frame: 2.5 years ]
    The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1


Secondary Outcome Measures :
  1. Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: 2.5 years ]
    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

  2. The overall survival in this population of patients. [ Time Frame: 2.5 years ]
    The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769935


Contacts
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Contact: youxin ji, MD 68665078 mdji001@gmail.com

Locations
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China, Shandong
Qingdao Central Hospital, Qingdao Cancer Hospital Recruiting
Qingdao, Shandong, China, 266042
Contact: youxin ji, M.D.    8653268665078    mdji001@gmail.com   
Principal Investigator: ketao lan, M.D.         
Sub-Investigator: chunling zhang, M.D.         
Sub-Investigator: youxin ji, M.D.         
Sponsors and Collaborators
Qingdao Central Hospital

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Responsible Party: Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT03769935     History of Changes
Other Study ID Numbers: QingdaoCH2018-12-02
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action