A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
- Conditions
- Small-Cell-Lung Cancer
- Interventions
- Registration Number
- NCT00144989
- Lead Sponsor
- Haruhiko Fukuda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Irinotecan and cisplatin after chemoradiotherapy Irinotecan and cisplatin after chemoradiotherapy 1 Etoposide and cisplatin after chemoradiotherapy Etoposide and cisplatin after chemoradiotherapy
- Primary Outcome Measures
Name Time Method overall survival during the study conduct
- Secondary Outcome Measures
Name Time Method late radiation morbidity during the study conduct serious adverse event during the study conduct chemotherapy after chemoradiotherapy during the study conduct progression-free survival during the study conduct adverse events of induction chemoradiotherapy during the study conduct
Trial Locations
- Locations (37)
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Kobe City General Hospital
🇯🇵Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Kumamoto Regional Medical Center Hospital
🇯🇵Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Okayama University Hospital
🇯🇵Okayama,Shikata-cho,2-5-1, Okayama, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
🇯🇵Habikino,Habikino,3-7-1, Osaka, Japan
Rinku General Medical Center
🇯🇵Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan
Graduate School of Medicine, Osaka City University
🇯🇵Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan
National Hospital Organization Toneyama National Hospital
🇯🇵Toyonaka,Toneyama,5-1-1, Osaka, Japan
Sizuoka Cancer Center
🇯🇵Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
National Hospital Organization, Dohoku National Hospital
🇯🇵Asahikawa,Hanasaki,7-4048, Hokkaido, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
🇯🇵Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Osaka General Medical Center
🇯🇵Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, Japan
Aichi Cancer Center,Aichi Hospital
🇯🇵Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
Kanagawa Cancer Center
🇯🇵Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Yokohama Mucipical Citizen's Hospital
🇯🇵Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan
Kinki University School of Medicine
🇯🇵Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Toranomon Hospital
🇯🇵Minato-ku,Toranomon,2-2-2, Tokyo, Japan
Kyushu University Hospital
🇯🇵Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Gifu Municipal Hospital
🇯🇵Gifu,Kashima-cho,7-1, Gifu, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
Cancer Institute Hospital
🇯🇵Koto-ku,Ariake,3-10-6, Tokyo, Japan
National Nishigunma Hospital
🇯🇵Shibukawa,Kanai,2854, Gunma, Japan
Osaka City General Hospital
🇯🇵Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Sakai,Nagasone,1180, Osaka, Japan
Hyogo Medical Center for Adults
🇯🇵Akashi,Kitaouji-cho,13-70, Hyogo, Japan
International Medical Center of Japan
🇯🇵Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata,Aoyagi,1800, Yamagata, Japan