Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)

Small Cell Lung Cancer Extensive Stage Clinical Trial

Official title:

Phase 2 Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02179528
• Other study ID #: BJCHDTC001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 24, 2014
• Last updated: September 10, 2014
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2014
• Source: Beijing Cancer Hospital
• Contact: Jie Wang, doctor
• Phone: 0086 108816456
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Extensive Stage
• Small Cell Lung Carcinoma

Intervention

Drug:
• Etoposide

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression		up to 12 months	Yes