Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)
Conditions
Small Cell Lung Cancer Extensive Stage
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Etoposide
Type: Drug
Overall Status
Not yet recruiting
Summary
Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. The objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. The investigators will use the peripheral blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathological diagnosis of small cell lung cancer

- Extensive stage according to American Veteran Staging System

- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1

- Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2

- Age≥18 years

- Adequate organ function

- Consent form according with Guideline for Good Clinical Practice of the International Conference on Harmonisation (ICH-GCP)guidelines

- The expected survival≥2 months

Exclusion Criteria:

- Pathological diagnosis of mixed small cell lung cancer

- Limited stage according to American Veteran Staging System

- Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator

- Known pre-existing interstitial lung disease

- Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator

- Any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator

- Pregnant or lactating women

- Active phase of hepatitis B virus infection,Active phase of hepatitis C virus infection or known HIV carriers
Location
Beijing Cancer Hospital
Beijing, Beijing, China
Status: Not yet recruiting
Contact: Jie Wang, doctor - 0086 1088196456 - zlhuxi@163.com
Start Date
September 2014
Completion Date
September 2017
Sponsors
Beijing Cancer Hospital
Source
Beijing Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page