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A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IP
Sponsored by
Clinical Research Center for Solid Tumor, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, Extensive Disease, Chemotherapy, Randomisation

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically diagnosed small cell lung cancer Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion) If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment) No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy) One or more measurable disease by RECIST criteria at least 18 years of age Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function Informed consent from patient which conforms to Institutional Review Board Exclusion Criteria: History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Uncontrolled serious infection Enrollment in other study within 30 days

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Yeungnam University Hospital
  • Daegu Catholic University Hospital
  • Gyeongsang National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Yonsei Cancer Center
  • Seoul Veterans Hospital
  • Kangnam St.Mary's Hospital
  • Asan Medical Center
  • Chung-Ang University Medical Center
  • Seoul Municipal Boramae Hospital
  • St.Vincent Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

EP

Arm Description

etoposide + cisplatin

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Objective response rate
Progression free survival
Safety profile

Full Information

First Posted
July 5, 2006
Last Updated
December 3, 2013
Sponsor
Clinical Research Center for Solid Tumor, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00349492
Brief Title
A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
Official Title
Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Research Center for Solid Tumor, Korea

4. Oversight

5. Study Description

Brief Summary
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1.5 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, Extensive Disease, Chemotherapy, Randomisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EP
Arm Type
Active Comparator
Arm Description
etoposide + cisplatin
Intervention Type
Drug
Intervention Name(s)
IP
Other Intervention Name(s)
irinotecan + cisplatin
Intervention Description
irinotecan+cisplatin
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
month
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
percent
Title
Progression free survival
Time Frame
month
Title
Safety profile
Time Frame
percent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically diagnosed small cell lung cancer Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion) If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment) No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy) One or more measurable disease by RECIST criteria at least 18 years of age Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function Informed consent from patient which conforms to Institutional Review Board Exclusion Criteria: History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Uncontrolled serious infection Enrollment in other study within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Seog Heo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon-si
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Daegu Catholic University Hospital
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-Si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
ZIP/Postal Code
134-791
Country
Korea, Republic of
Facility Name
Kangnam St.Mary's Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Chung-Ang University Medical Center
City
Seoul
ZIP/Postal Code
151-756
Country
Korea, Republic of
Facility Name
Seoul Municipal Boramae Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
St.Vincent Hospital
City
Suwon
ZIP/Postal Code
422-723
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

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