- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144989
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
September 20, 2016 updated by: Haruhiko Fukuda
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
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.
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
281
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
- Aichi Cancer Center,Aichi Hospital
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Chiba
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Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Gifu
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Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
- Gifu Municipal Hospital
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Gunma
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Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
- Gunma Prefectural Cancer Center
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Shibukawa,Kanai,2854, Gunma, Japan, 377-8511
- National Nishigunma Hospital
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Hokkaido
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Asahikawa,Hanasaki,7-4048, Hokkaido, Japan, 070-8644
- National Hospital Organization, Dohoku National Hospital
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Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Hyogo
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Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
- Hyogo Medical Center for Adults
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Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan, 650-0046
- Kobe City General Hospital
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Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan, 663-8501
- Hyogo College of Medicine
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Ibaraki
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Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
- Ibaraki Kenritsu Chuo Hospital & Cancer Center
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Kanagawa
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Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
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Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
- Yokohama Mucipical Citizen's Hospital
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Kumamoto
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Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
- Kumamoto Regional Medical Center Hospital
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Miyagi
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Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-0874
- Tohoku University Hospital
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Niigata
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Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama
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Okayama,Shikata-cho,2-5-1, Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka
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Habikino,Habikino,3-7-1, Osaka, Japan, 583-8588
- Osaka Prefectural Medical Center for Respiratory and Allergic Disease
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Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan, 598-0048
- Rinku General Medical Center
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Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan, 545-0051
- Graduate School of Medicine, Osaka City University
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Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
- Osaka Medical Center for Cancer and Cardiovascular Diseases
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Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
- Osaka City General Hospital
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Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, Japan, 558-8558
- Osaka General Medical Center
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Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
- Kinki University School of Medicine
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Sakai,Nagasone,1180, Osaka, Japan, 591-8555
- National Hospital Organization Kinki-Chuo Chest Medical Center
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Toyonaka,Toneyama,5-1-1, Osaka, Japan, 560-8552
- National Hospital Organization Toneyama National Hospital
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Saitama
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Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka
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Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
- Sizuoka Cancer Center
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Tochigi
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Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
- Tochigi Cancer Center
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Tokyo
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Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
- Cancer Institute Hospital
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Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
- Toranomon Hospital
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Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
- International Medical Center of Japan
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Yamagata
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Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
- Yamagata Prefectural Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cytologically, histologically proven small-cell lung cancer
- limited disease
- age 20-70 years old
- performance status of 0-1
- measurable disease
- no prior treatment for small-cell lung cancer
- no history of chemotherapy
- adequate organ functions
- written informed consent
Exclusion Criteria:
- pericardial effusion
- active concomitant malignancy
- pregnant or lactating women
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 1
Etoposide and cisplatin after chemoradiotherapy
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Etoposide and cisplatin after chemoradiotherapy
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EXPERIMENTAL: 2
Irinotecan and cisplatin after chemoradiotherapy
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Irinotecan and cisplatin after chemoradiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: during the study conduct
|
during the study conduct
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adverse events of induction chemoradiotherapy
Time Frame: during the study conduct
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during the study conduct
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chemotherapy after chemoradiotherapy
Time Frame: during the study conduct
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during the study conduct
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late radiation morbidity
Time Frame: during the study conduct
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during the study conduct
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serious adverse event
Time Frame: during the study conduct
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during the study conduct
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progression-free survival
Time Frame: during the study conduct
|
during the study conduct
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Yutaka Nishiwaki, MD, National Cancer Center Hospital East
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (ESTIMATE)
September 5, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Etoposide
- Cisplatin
- Irinotecan
Other Study ID Numbers
- JCOG0202-MF
- C000000095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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