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

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 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
U.S. FDA Resources

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

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 ]

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

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.

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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 identifier (NCT number): NCT00144989

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
National Cancer Center Hospital East
Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, Japan, 377-8511
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, Japan, 070-8644
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan, 650-0046
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan, 663-8501
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-0874
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama, Japan, 700-8558
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, Japan, 583-8588
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan, 598-0048
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan, 545-0051
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
Osaka General Medical Center
Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, Japan, 558-8558
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, Japan, 591-8555
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, Japan, 560-8552
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Yutaka Nishiwaki, MD National Cancer Center Hospital East

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group Identifier: NCT00144989     History of Changes
Other Study ID Numbers: JCOG0202-MF
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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors