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

Primary Purpose

Small Cell Lung Cancer Extensive Stage

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Etoposide

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

etoposide,maintenance therapy

blank control

Arm Description

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

blank control

Outcomes

Primary Outcome Measures

Time to Disease Progression

Secondary Outcome Measures

Full Information

NCT ID

NCT02179528

First Posted

June 24, 2014

Last Updated

September 10, 2014

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT02179528

Brief Title

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

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer Extensive Stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

etoposide,maintenance therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

blank control

Arm Type

No Intervention

Arm Description

blank control

Intervention Type

Drug

Intervention Name(s)

Etoposide

Primary Outcome Measure Information:

Title

Time to Disease Progression

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Wang, doctor

Phone

0086 108816456

zlhuxi@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Wang, doctor

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100042

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Wang, doctor

Phone

0086 1088196456

zlhuxi@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

33569214

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.

Results Reference

derived

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

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