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

NCT ID: NCT00144989

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small-Cell-Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Etoposide and cisplatin after chemoradiotherapy

Group Type ACTIVE_COMPARATOR

Etoposide and cisplatin after chemoradiotherapy

Intervention Type DRUG

Etoposide and cisplatin after chemoradiotherapy

2

Irinotecan and cisplatin after chemoradiotherapy

Group Type EXPERIMENTAL

Irinotecan and cisplatin after chemoradiotherapy

Intervention Type DRUG

Irinotecan and cisplatin after chemoradiotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etoposide and cisplatin after chemoradiotherapy

Etoposide and cisplatin after chemoradiotherapy

Intervention Type DRUG

Irinotecan and cisplatin after chemoradiotherapy

Irinotecan and cisplatin after chemoradiotherapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role collaborator

Haruhiko Fukuda

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Haruhiko Fukuda

JCOG Data Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yutaka Nishiwaki, MD

Role: STUDY_CHAIR

National Cancer Center Hospital East

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Site Status

Aichi Cancer Center,Aichi Hospital

Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Site Status

Kyushu University Hospital

Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Site Status

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Site Status

Gunma Prefectural Cancer Center

Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

Site Status

National Nishigunma Hospital

Shibukawa,Kanai,2854, Gunma, Japan

Site Status

National Hospital Organization, Dohoku National Hospital

Asahikawa,Hanasaki,7-4048, Hokkaido, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan

Site Status

Hyogo Medical Center for Adults

Akashi,Kitaouji-cho,13-70, Hyōgo, Japan

Site Status

Kobe City General Hospital

Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyōgo, Japan

Site Status

Hyogo College of Medicine

Nishinomiya,Mukogawa-cho,1-1, Hyōgo, Japan

Site Status

Ibaraki Kenritsu Chuo Hospital & Cancer Center

Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan

Site Status

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Site Status

Yokohama Mucipical Citizen's Hospital

Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan

Site Status

Kumamoto Regional Medical Center Hospital

Kumamoto,Honjo,5-16-10, Kumamoto, Japan

Site Status

Tohoku University Hospital

Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Site Status

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Site Status

Okayama University Hospital

Okayama,Shikata-cho,2-5-1, Okayama-ken, Japan

Site Status

Osaka Prefectural Medical Center for Respiratory and Allergic Disease

Habikino,Habikino,3-7-1, Osaka, Japan

Site Status

Rinku General Medical Center

Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan

Site Status

Graduate School of Medicine, Osaka City University

Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan

Site Status

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Site Status

Osaka City General Hospital

Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan

Site Status

Osaka General Medical Center

Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, Japan

Site Status

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan

Site Status

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai,Nagasone,1180, Osaka, Japan

Site Status

National Hospital Organization Toneyama National Hospital

Toyonaka,Toneyama,5-1-1, Osaka, Japan

Site Status

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, Japan

Site Status

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan

Site Status

Tochigi Cancer Center

Utsunomiya,Yohnan,4-9-13, Tochigi, Japan

Site Status

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

Site Status

Cancer Institute Hospital

Koto-ku,Ariake,3-10-6, Tokyo, Japan

Site Status

Toranomon Hospital

Minato-ku,Toranomon,2-2-2, Tokyo, Japan

Site Status

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan

Site Status

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24309370 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C000000095

Identifier Type: -

Identifier Source: secondary_id

JCOG0202-MF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.