Clinical trial NCT00144989: A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small-Cell-Lung Cancer
Keywords: Small-cell lung cancer
Limited-Stage Small-Cell Lung Cancer
Combined modality therapy
chemotherapy
radiotherapy
Irinotecan
Cisplatin
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-05
Enrollment: 281
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: during the study conduct
Secondary outcomes:
measure: adverse events of induction chemoradiotherapy
timeFrame: during the study conduct
measure: chemotherapy after chemoradiotherapy
timeFrame: during the study conduct
measure: late radiation morbidity
timeFrame: during the study conduct
measure: serious adverse event
timeFrame: during the study conduct
measure: progression-free survival
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Okazaki,Kake-machi,Kuriyado,18
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: Kashiwa-shi,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Gifu,Kashima-cho,7-1
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Shibukawa,Kanai,2854
country: Japan
facility: National Nishigunma Hospital
state: Gunma
city: Asahikawa,Hanasaki,7-4048
country: Japan
facility: National Hospital Organization, Dohoku National Hospital
state: Hokkaido
city: Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi,Kitaouji-cho,13-70
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: Kobe,Chuo-ku,Minatojimanakamachi,4-6
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Nishinomiya,Mukogawa-cho,1-1
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Hodogaya-ku,Okazawa-cho,56
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: Kumamoto,Honjo,5-16-10
country: Japan
facility: Kumamoto Regional Medical Center Hospital
state: Kumamoto
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Okayama,Shikata-cho,2-5-1
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Habikino,Habikino,3-7-1
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Disease
state: Osaka
city: Izumisano,rinku-ohrai-kita,2-23
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Osaka,Abeno-ku,Asahi-machi,1-5-7
country: Japan
facility: Graduate School of Medicine, Osaka City University
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai,Nagasone,1180
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
state: Osaka
city: Toyonaka,Toneyama,5-1-1
country: Japan
facility: National Hospital Organization Toneyama National Hospital
state: Osaka
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Minato-ku,Toranomon,2-2-2
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-ku,Toyama,1-21-1
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: National Cancer Center Hospital East
name: Yutaka Nishiwaki, MD
role: STUDY_CHAIR
References:
citation: 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.