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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Small-Cell-Lung Cancer Drug: Etoposide and cisplatin after chemoradiotherapy Drug: Irinotecan and cisplatin after chemoradiotherapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2002
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Etoposide and cisplatin after chemoradiotherapy
 Drug: Etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
Experimental: 2
Irinotecan and cisplatin after chemoradiotherapy
 Drug: Irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. adverse events of induction chemoradiotherapy [ Time Frame: during the study conduct ]
  2. chemotherapy after chemoradiotherapy [ Time Frame: during the study conduct ]
  3. late radiation morbidity [ Time Frame: during the study conduct ]
  4. serious adverse event [ Time Frame: during the study conduct ]
  5. progression-free survival [ Time Frame: during the study conduct ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144989


Locations
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Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Yutaka Nishiwaki, MD National Cancer Center Hospital East
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00144989    
Other Study ID Numbers: JCOG0202-MF
C000000095
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
Small-cell lung cancer
Limited-Stage Small-Cell Lung Cancer
Combined modality therapy
chemotherapy
 radiotherapy
Irinotecan
Cisplatin
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Cisplatin
Irinotecan
Etoposide
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors