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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00144989
First received: September 1, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Small-Cell-Lung Cancer
Drug: Etoposide and cisplatin after chemoradiotherapy
Drug: Irinotecan and cisplatin after chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events of induction chemoradiotherapy [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
  • chemotherapy after chemoradiotherapy [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • late radiation morbidity [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
  • serious adverse event [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: September 2002
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144989

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00144989     History of Changes
Other Study ID Numbers: JCOG0202-MF  C000000095 
Study First Received: September 1, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
Small-cell lung cancer
Limited-Stage Small-Cell Lung Cancer
Combined modality therapy
chemotherapy
radiotherapy
Irinotecan
Cisplatin

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Camptothecin
Etoposide
Etoposide phosphate
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016