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

Primary Purpose

Small-Cell-Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Etoposide and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-Cell-Lung Cancer focused on measuring Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aichi Cancer Center Hospital
  • Aichi Cancer Center,Aichi Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Kyushu University Hospital
  • Gifu Municipal Hospital
  • Gunma Prefectural Cancer Center
  • National Nishigunma Hospital
  • National Hospital Organization, Dohoku National Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Hyogo Medical Center for Adults
  • Kobe City General Hospital
  • Hyogo College of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Kanagawa Cancer Center
  • Yokohama Mucipical Citizen's Hospital
  • Kumamoto Regional Medical Center Hospital
  • Tohoku University Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • Osaka Prefectural Medical Center for Respiratory and Allergic Disease
  • Rinku General Medical Center
  • Graduate School of Medicine, Osaka City University
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Osaka City General Hospital
  • Osaka General Medical Center
  • Kinki University School of Medicine
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • National Hospital Organization Toneyama National Hospital
  • Saitama Cancer Center
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • Toranomon Hospital
  • International Medical Center of Japan
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Etoposide and cisplatin after chemoradiotherapy

Irinotecan and cisplatin after chemoradiotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

adverse events of induction chemoradiotherapy
chemotherapy after chemoradiotherapy
late radiation morbidity
serious adverse event
progression-free survival

Full Information

First Posted
September 1, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00144989
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-Cell-Lung Cancer
Keywords
Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Etoposide and cisplatin after chemoradiotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Irinotecan and cisplatin after chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Etoposide and cisplatin after chemoradiotherapy
Intervention Description
Etoposide and cisplatin after chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Irinotecan and cisplatin after chemoradiotherapy
Intervention Description
Irinotecan and cisplatin after chemoradiotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
adverse events of induction chemoradiotherapy
Time Frame
during the study conduct
Title
chemotherapy after chemoradiotherapy
Time Frame
during the study conduct
Title
late radiation morbidity
Time Frame
during the study conduct
Title
serious adverse event
Time Frame
during the study conduct
Title
progression-free survival
Time Frame
during the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutaka Nishiwaki, MD
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Cancer Center,Aichi Hospital
City
Okazaki,Kake-machi,Kuriyado,18
State/Province
Aichi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kyushu University Hospital
City
Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu,Kashima-cho,7-1
State/Province
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota,Takabayashi-nishi-cho,617-1
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Nishigunma Hospital
City
Shibukawa,Kanai,2854
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
National Hospital Organization, Dohoku National Hospital
City
Asahikawa,Hanasaki,7-4048
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
Akashi,Kitaouji-cho,13-70
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City General Hospital
City
Kobe,Chuo-ku,Minatojimanakamachi,4-6
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya,Mukogawa-cho,1-1
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Yokohama Mucipical Citizen's Hospital
City
Yokohama,Hodogaya-ku,Okazawa-cho,56
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
Kumamoto,Honjo,5-16-10
State/Province
Kumamoto
ZIP/Postal Code
860-0811
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-0874
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama,Shikata-cho,2-5-1
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
City
Habikino,Habikino,3-7-1
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano,rinku-ohrai-kita,2-23
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Graduate School of Medicine, Osaka City University
City
Osaka,Abeno-ku,Asahi-machi,1-5-7
State/Province
Osaka
ZIP/Postal Code
545-0051
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56
State/Province
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai,Nagasone,1180
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
National Hospital Organization Toneyama National Hospital
City
Toyonaka,Toneyama,5-1-1
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku,Toranomon,2-2-2
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku,Toyama,1-21-1
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24309370
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

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