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A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

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ClinicalTrials.gov Identifier: NCT00144989
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE September 2002
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)		 overall survival [ Time Frame: during the study conduct ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)		 overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • adverse events of induction chemoradiotherapy [ Time Frame: during the study conduct ]
  • chemotherapy after chemoradiotherapy [ Time Frame: during the study conduct ]
  • late radiation morbidity [ Time Frame: during the study conduct ]
  • serious adverse event [ Time Frame: during the study conduct ]
  • progression-free survival [ Time Frame: during the study conduct ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • adverse events of induction chemoradiotherapy
  • chemotherapy after chemoradiotherapy
  • late radiation morbidity
  • serious adverse event
  • progression-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
Official Title  ICMJE A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF
Brief Summary To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
Detailed Description The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small-Cell-Lung Cancer
Intervention  ICMJE
  • Drug: Etoposide and cisplatin after chemoradiotherapy
    Etoposide and cisplatin after chemoradiotherapy
  • Drug: Irinotecan and cisplatin after chemoradiotherapy
    Irinotecan and cisplatin after chemoradiotherapy
Study Arms  ICMJE
  • Active Comparator: 1
    Etoposide and cisplatin after chemoradiotherapy
    Intervention: Drug: Etoposide and cisplatin after chemoradiotherapy
  • Experimental: 2
    Irinotecan and cisplatin after chemoradiotherapy
    Intervention: Drug: Irinotecan and cisplatin after chemoradiotherapy
Publications * Kubota K, Hida T, Ishikura S, Mizusawa J, Nishio M, Kawahara M, Yokoyama A, Imamura F, Takeda K, Negoro S, Harada M, Okamoto H, Yamamoto N, Shinkai T, Sakai H, Matsui K, Nakagawa K, Shibata T, Saijo N, Tamura T; Japan Clinical Oncology Group. Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy (JCOG0202): a randomised phase 3 study. Lancet Oncol. 2014 Jan;15(1):106-13. doi: 10.1016/S1470-2045(13)70511-4. Epub 2013 Dec 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2009)		 281
Original Enrollment  ICMJE
 (submitted: September 1, 2005)		 270
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. cytologically, histologically proven small-cell lung cancer
  2. limited disease
  3. age 20-70 years old
  4. performance status of 0-1
  5. measurable disease
  6. no prior treatment for small-cell lung cancer
  7. no history of chemotherapy
  8. adequate organ functions
  9. written informed consent

Exclusion Criteria:

  1. pericardial effusion
  2. active concomitant malignancy
  3. pregnant or lactating women
  4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00144989
Other Study ID Numbers  ICMJE JCOG0202-MF
C000000095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Haruhiko Fukuda, Japan Clinical Oncology Group
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Haruhiko Fukuda
Original Study Sponsor  ICMJE Japan Clinical Oncology Group
Collaborators  ICMJE Ministry of Health, Labour and Welfare, Japan
Investigators  ICMJE
Study Chair: Yutaka Nishiwaki, MD National Cancer Center Hospital East
PRS Account Japan Clinical Oncology Group
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP