NCT02179528

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 12, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

June 24, 2014

Last Update Submit

September 10, 2014

Conditions

Small Cell Lung Cancer Extensive Stage

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Progression

    up to 12 months

Study Arms (2)

etoposide,maintenance therapy

ACTIVE COMPARATOR

etoposide,25mg qd d1-20，repeat every 28 days

Drug: Etoposide

blank control

NO INTERVENTION

blank control

Interventions

EtoposideDRUG
etoposide,maintenance therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100042, China

Location

Related Publications (1)

  • 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.

    PMID: 33569214DERIVED

MeSH Terms

Interventions

Etoposide

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Jie Wang, doctor

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Wang, doctor

CONTACT

0086 108816456zlhuxi@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of thoracic cancer department

Study Record Dates

First Submitted

June 24, 2014

First Posted

July 2, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

September 12, 2014

Record last verified: 2014-06

Locations

CN(1)