Small-Cell-Lung Cancer Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 281 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hyogo Medical Center for Adults | Akashi,Kitaouji-cho,13-70 | Hyogo |
| Japan | National Hospital Organization, Dohoku National Hospital | Asahikawa,Hanasaki,7-4048 | Hokkaido |
| Japan | National Cancer Center Hospital | Chuo-ku,Tsukiji,5-1-1 | Tokyo |
| Japan | Gifu Municipal Hospital | Gifu,Kashima-cho,7-1 | Gifu |
| Japan | Osaka Prefectural Medical Center for Respiratory and Allergic Disease | Habikino,Habikino,3-7-1 | Osaka |
| Japan | Kyushu University Hospital | Higashi-ku,Maidashi,3-1-1 | Fukuoka |
| Japan | Rinku General Medical Center | Izumisano,rinku-ohrai-kita,2-23 | Osaka |
| Japan | National Cancer Center Hospital East | Kashiwa-shi,Kashiwanoha,6-5-1 | Chiba |
| Japan | Saitama Cancer Center | Kita-adachi,Ina,Komuro,818 | Saitama |
| Japan | Kobe City General Hospital | Kobe,Chuo-ku,Minatojimanakamachi,4-6 | Hyogo |
| Japan | Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo |
| Japan | Kumamoto Regional Medical Center Hospital | Kumamoto,Honjo,5-16-10 | Kumamoto |
| Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama,Horinouchi,13 | Ehime |
| Japan | Toranomon Hospital | Minato-ku,Toranomon,2-2-2 | Tokyo |
| Japan | Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi |
| Japan | Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata |
| Japan | Ibaraki Kenritsu Chuo Hospital & Cancer Center | Nishi-ibarakigun,Tomobemachi,Koibuchi,6528 | Ibaraki |
| Japan | Hyogo College of Medicine | Nishinomiya,Mukogawa-cho,1-1 | Hyogo |
| Japan | Okayama University Hospital | Okayama,Shikata-cho,2-5-1 | Okayama |
| Japan | Aichi Cancer Center,Aichi Hospital | Okazaki,Kake-machi,Kuriyado,18 | Aichi |
| Japan | Graduate School of Medicine, Osaka City University | Osaka,Abeno-ku,Asahi-machi,1-5-7 | Osaka |
| Japan | Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka,Higashinari-ku,Nakamichi,1-3-3 | Osaka |
| Japan | Osaka City General Hospital | Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22 | Osaka |
| Japan | Osaka General Medical Center | Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56 | Osaka |
| Japan | Kinki University School of Medicine | Osaka-Sayama,Ohno-higashi,377-2 | Osaka |
| Japan | Gunma Prefectural Cancer Center | Ota,Takabayashi-nishi-cho,617-1 | Gunma |
| Japan | National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai,Nagasone,1180 | Osaka |
| Japan | National Hospital Organization Hokkaido Cancer Center | Sapporo,Shiroishi-ku,Kikusui,4-2-3-54 | Hokkaido |
| Japan | Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi |
| Japan | National Nishigunma Hospital | Shibukawa,Kanai,2854 | Gunma |
| Japan | International Medical Center of Japan | Shinjuku-ku,Toyama,1-21-1 | Tokyo |
| Japan | Sizuoka Cancer Center | Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007 | Shizuoka |
| Japan | National Hospital Organization Toneyama National Hospital | Toyonaka,Toneyama,5-1-1 | Osaka |
| Japan | Tochigi Cancer Center | Utsunomiya,Yohnan,4-9-13 | Tochigi |
| Japan | Yamagata Prefectural Central Hospital | Yamagata,Aoyagi,1800 | Yamagata |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Haruhiko Fukuda | Ministry of Health, Labour and Welfare, Japan |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | during the study conduct | No | |
| Secondary | adverse events of induction chemoradiotherapy | during the study conduct | Yes | |
| Secondary | chemotherapy after chemoradiotherapy | during the study conduct | No | |
| Secondary | late radiation morbidity | during the study conduct | Yes | |
| Secondary | serious adverse event | during the study conduct | Yes | |
| Secondary | progression-free survival | during the study conduct | No |