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A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
This study is currently recruiting participants.
Verified by Clinical Research Center for Solid Tumor, Korea, July 2006
Sponsored by: Clinical Research Center for Solid Tumor, Korea
Information provided by: Clinical Research Center for Solid Tumor, Korea
ClinicalTrials.gov Identifier: NCT00349492
  Purpose

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


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Etoposide/Cisplatin, Irinotecan/Cisplatin
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Etoposide Cisplatin Irinotecan Irinotecan hydrochloride Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Clinical Research Center for Solid Tumor, Korea:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Objective response rate
  • Progression free survival
  • Safety profile

Estimated Enrollment: 372
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349492

Contacts
Contact: Dae Seog Heo, MD, PhD +82-2-2072-2857 heo1013@snu.ac.kr
Contact: Mi Rang Shim, RN +82-2-2072-1742 li_ming@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Dae Seog Heo, M.D            
Kangnam St.Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 137-040
Principal Investigator: Jin-Hyoung Kang, M.D.            
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-746
Principal Investigator: Seung Sei Lee, M.D.            
Gyeongsang National University Hospital Not yet recruiting
Jinju, Korea, Republic of, 660-702
Principal Investigator: Hun-Gu Kim, M.D            
Daegu Catholic University Hospital Not yet recruiting
Daegu, Korea, Republic of, 705-718
Principal Investigator: Sung Hwa Bae, M.D.            
Seoul Municipal Boramae Hospital Not yet recruiting
Seoul, Korea, Republic of, 156-707
Principal Investigator: Byung-Su Kim, M.D.            
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of, 134-791
Principal Investigator: Bong-Seog Kim, M.D.            
Chung-Ang University Medical Center Not yet recruiting
Seoul, Korea, Republic of, 151-756
Principal Investigator: Joung Soon Jang, M.D.            
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Sang-We Kim, M.D.            
St.Vincent Hospital Recruiting
Suwon, Korea, Republic of, 422-723
Principal Investigator: Hoon-Kyo Kim, M.D.            
Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of, 120-752
Principal Investigator: Joo-Hang Kim, M.D.            
Soonchunhyang University Bucheon Hospital Not yet recruiting
Bucheon-si, Korea, Republic of, 420-767
Principal Investigator: Dae-Sik Hong, M.D.            
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 705-717
Principal Investigator: Kyung Hee Lee, M.D.            
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-Si, Korea, Republic of, 463-707
Principal Investigator: Jong-Seok Lee, M.D.            
Sponsors and Collaborators
Clinical Research Center for Solid Tumor, Korea
Investigators
Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University Hospital
  More Information

Study ID Numbers: CRCST-L-0001
Study First Received: July 5, 2006
Last Updated: July 5, 2006
ClinicalTrials.gov Identifier: NCT00349492  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Clinical Research Center for Solid Tumor, Korea:
Small Cell Lung Cancer
Extensive Disease
Chemotherapy
Randomisation

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Irinotecan
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009