A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

Condition(s) targeted: Small-Cell-Lung Cancer

Intervention: Etoposide and cisplatin after chemoradiotherapy (Drug); Irinotecan and cisplatin after chemoradiotherapy (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Japan Clinical Oncology Group

Official(s) and/or principal investigator(s):
Yutaka Nishiwaki, MD, Study Chair, Affiliation: National Cancer Center Hospital East

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: overall survival

Secondary outcome:

adverse events of induction chemoradiotherapy

chemotherapy after chemoradiotherapy

late radiation morbidity

serious adverse event

progression-free survival

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.

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Aichi Cancer Center Hospital, 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi 464-8681, Japan

Aichi Cancer Center,Aichi Hospital, 18,Kuriyado,Kake-machi,Okazaki, Aichi 444-0011, Japan

National Cancer Center Hospital East, 6-5-1　kashiwanoha Kashiwa-shi, Chiba 277-8577, Japan

National Hospital Organization Shikoku Cancer Center, 13,Horinouchi,Matsuyama, Ehime 790-0007, Japan

Kyushu University Hospital, 3-1-1,Maidashi,Higashi-ku, Fukuoka 812-8582, Japan

Gifu Municipal Hospital, 7-1,Kashima-cho,Gifu, Gifu 500-8323, Japan

National Nishigunma Hospital, 2854, Kanai,Shibukawa, Gunma 377-8511, Japan

Gunma Prefectural Cancer Center, 617-1,Takabayashi-nishi-cho,Ota, Gunma 373-8550, Japan

National Hospital Organization, Dohoku National Hospital, 7-4048,Hanasaki,Asahikawa, Hokkaido 070-8644, Japan

National Hospital Organization Hokkaido Cancer Center, 4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido 003-0804, Japan

Kobe City General Hospital, 4-6,Minatojimanakamachi,Chuo-ku,Kobe, Hyogo 650-0046, Japan

Hyogo College of Medicine, 1-1,Mukogawa-cho,Nishinomiya, Hyogo 663-8501, Japan

Hyogo Medical Center for Adults, 13-70,Kitaouji-cho,Akashi, Hyogo 673-8558, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center, 6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki 309-1793, Japan

Kanagawa Cancer Center, 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa 241-0815, Japan

Yokohama Mucipical Citizen's Hospital, 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa 240-8555, Japan

Kumamoto Regional Medical Center Hospital, 5-16-10,Honjo,Kumamoto, Kumamoto 860-0811, Japan

Tohoku University Hospital, 1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-0874, Japan

Niigata Cancer Center Hospital, 2-15-3,Kawagishi-cho,Niigata, Niigata 951-8566, Japan

Okayama University Hospital, 2-5-1,Shikata-cho,Okayama, Okayama 700-8558, Japan

Graduate School of Medicine, Osaka City University, 1-5-7,Asahi-machi,Abeno-ku,Osaka, Osaka 545-0051, Japan

Kinki University School of Medicine, 377-2,Ohno-higashi,Osaka-Sayama, Osaka 589-8511, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka 537-8511, Japan

Osaka Prefectural Medical Center for Respiratory and Allergic Disease, 3-7-1,Habikino,Habikino, Osaka 583-8588, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center, 1180,Nagasone,Sakai, Osaka 591-8555, Japan

National Hospital Organization Toneyama National Hospital, 5-1-1,Toneyama,Toyonaka, Osaka 560-8552, Japan

Osaka General Medical Center, 3-1-56,Bandai-higashi,Sumiyoshi-ku,Osaka, Osaka 558-8558, Japan

Osaka City General Hospital, 2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka, Osaka 534-0021, Japan

Rinku General Medical Center, 2-23,rinku-ohrai-kita,Izumisano, Osaka 598-0048, Japan

Saitama Cancer Center, 818,Komuro,Ina,Kita-adachi, Saitama 362-0806, Japan

Sizuoka Cancer Center, 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan

Tochigi Cancer Center, 4-9-13,Yohnan,Utsunomiya, Tochigi 320-0834, Japan

National Cancer Center Hospital, 5-1-1,Tsukiji,Chuo-ku, Tokyo 104-0045, Japan

International Medical Center of Japan, 1-21-1,Toyama,Shinjuku-ku, Tokyo 162-8655, Japan

Cancer Institute Hospital, 3-10-6,Ariake,Koto-ku, Tokyo 135-8550, Japan

Toranomon Hospital, 2-2-2,Toranomon,Minato-ku, Tokyo 105-8470, Japan

Yamagata Prefectural Central Hospital, 1800,Aoyagi,Yamagata, Yamagata 990-2292, Japan

Starting date: September 2002
Ending date: September 2011
Last updated: March 8, 2007