Clinical trial NCT02179528: Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)
Official title: Phase 2 Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer Extensive Stage
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Time to Disease Progression
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jie Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang C, Duan J, He Z, Yang L, Yang S, Zhang Z, Liu Y, Wan R, Lin L, Wu X, Wang W, Wang Q, Wang J. The benefits of etoposide capsules as maintenance therapy for patients with extensive-stage small cell lung cancer: a prospective two-stage, two-center study. J Thorac Dis. 2021 Jan;13(1):343-352. doi: 10.21037/jtd-21-106.