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

September 20, 2016 updated by: Haruhiko Fukuda

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
        • Aichi Cancer Center,Aichi Hospital
    • Chiba
      • Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
    • Gifu
      • Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
        • Gifu Municipal Hospital
    • Gunma
      • Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
      • Shibukawa,Kanai,2854, Gunma, Japan, 377-8511
        • National Nishigunma Hospital
    • Hokkaido
      • Asahikawa,Hanasaki,7-4048, Hokkaido, Japan, 070-8644
        • National Hospital Organization, Dohoku National Hospital
      • Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Hyogo
      • Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
        • Hyogo Medical Center for Adults
      • Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan, 650-0046
        • Kobe City General Hospital
      • Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine
    • Ibaraki
      • Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
        • Ibaraki Kenritsu Chuo Hospital & Cancer Center
    • Kanagawa
      • Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
        • Kanagawa Cancer Center
      • Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
        • Yokohama Mucipical Citizen's Hospital
    • Kumamoto
      • Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
        • Kumamoto Regional Medical Center Hospital
    • Miyagi
      • Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-0874
        • Tohoku University Hospital
    • Niigata
      • Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Okayama
      • Okayama,Shikata-cho,2-5-1, Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Osaka
      • Habikino,Habikino,3-7-1, Osaka, Japan, 583-8588
        • Osaka Prefectural Medical Center for Respiratory and Allergic Disease
      • Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan, 598-0048
        • Rinku General Medical Center
      • Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan, 545-0051
        • Graduate School of Medicine, Osaka City University
      • Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
        • Kinki University School of Medicine
      • Sakai,Nagasone,1180, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
      • Toyonaka,Toneyama,5-1-1, Osaka, Japan, 560-8552
        • National Hospital Organization Toneyama National Hospital
    • Saitama
      • Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
        • Sizuoka Cancer Center
    • Tochigi
      • Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital
      • Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
        • International Medical Center of Japan
    • Yamagata
      • Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
        • Yamagata Prefectural Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Etoposide and cisplatin after chemoradiotherapy
Drug: Etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
EXPERIMENTAL: 2
Irinotecan and cisplatin after chemoradiotherapy
Drug: Irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: during the study conduct
during the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events of induction chemoradiotherapy
Time Frame: during the study conduct
during the study conduct
chemotherapy after chemoradiotherapy
Time Frame: during the study conduct
during the study conduct
late radiation morbidity
Time Frame: during the study conduct
during the study conduct
serious adverse event
Time Frame: during the study conduct
during the study conduct
progression-free survival
Time Frame: during the study conduct
during the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haruhiko Fukuda

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Yutaka Nishiwaki, MD, National Cancer Center Hospital East

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0202-MF
  • C000000095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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