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

September 10, 2014 updated by: Jie Wang, Peking University Cancer Hospital & Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jie Wang, doctor
  • Phone Number: 0086 108816456
  • Email: zlhuxi@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100042
        • Beijing Cancer Hospital
        • Contact:
          • Jie Wang, doctor
          • Phone Number: 0086 1088196456
          • Email: zlhuxi@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: etoposide,maintenance therapy
etoposide,25mg qd d1-20，repeat every 28 days
Drug: Etoposide
No Intervention: blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: jie wang, doctor, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCHDTC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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