A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
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
2 other identifiers
interventional
281
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2002
Longer than P75 for phase_3
37 active sites
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
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 22, 2016
September 1, 2016
9 years
September 1, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
during the study conduct
Secondary Outcomes (5)
adverse events of induction chemoradiotherapy
during the study conduct
chemotherapy after chemoradiotherapy
during the study conduct
late radiation morbidity
during the study conduct
serious adverse event
during the study conduct
progression-free survival
during the study conduct
Study Arms (2)
1
ACTIVE COMPARATOREtoposide and cisplatin after chemoradiotherapy
2
EXPERIMENTALIrinotecan and cisplatin after chemoradiotherapy
Interventions
Irinotecan and cisplatin after chemoradiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pericardial effusion
- active concomitant malignancy
- pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (37)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011, Japan
National Cancer Center Hospital East
Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, 500-8323, Japan
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550, Japan
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, 377-8511, Japan
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, 070-8644, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804, Japan
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558, Japan
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyōgo, 650-0046, Japan
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyōgo, 663-8501, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-0874, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama-ken, 700-8558, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, 583-8588, Japan
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, 598-0048, Japan
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, 545-0051, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021, Japan
Osaka General Medical Center
Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, 558-8558, Japan
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, 591-8555, Japan
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, 560-8552, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470, Japan
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655, Japan
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan
Related Publications (1)
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.
PMID: 24309370DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yutaka Nishiwaki, MD
National Cancer Center Hospital East
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
September 1, 2002
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 22, 2016
Record last verified: 2016-09