NCT00349492

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

March 1, 2012

Enrollment Period

5.5 years

First QC Date

July 5, 2006

Last Update Submit

December 3, 2013

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung CancerExtensive DiseaseChemotherapyRandomisation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    month

Secondary Outcomes (3)

  • Objective response rate

    percent

  • Progression free survival

    month

  • Safety profile

    percent

Study Arms (1)

EP

ACTIVE COMPARATOR

etoposide + cisplatin

Drug: IP

Interventions

IPDRUG

irinotecan+cisplatin

Also known as: irinotecan + cisplatin
EP

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Soonchunhyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

Location

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Daegu Catholic University Hospital

Daegu, 705-718, South Korea

Location

Gyeongsang National University Hospital

Jinju, 660-702, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

Seoul Veterans Hospital

Seoul, 134-791, South Korea

Location

Kangnam St.Mary's Hospital

Seoul, 137-040, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Chung-Ang University Medical Center

Seoul, 151-756, South Korea

Location

Seoul Municipal Boramae Hospital

Seoul, 156-707, South Korea

Location

St.Vincent Hospital

Suwon, 422-723, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

IrinotecanCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Dae Seog Heo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dae Seog Heo, professor

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 7, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2011

Study Completion

October 1, 2013

Last Updated

December 4, 2013

Record last verified: 2012-03

Locations

KR(14)