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

Sponsor:	Japan Clinical Oncology Group
Collaborator:	Ministry of Health, Labour and Welfare, Japan
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00144989

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 III

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Irinotecan U 101440E Etoposide phosphate Irinotecan hydrochloride

U.S. FDA Resources

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
Estimated Study Completion Date:	September 2011
Estimated 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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

Locations

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

Sponsors and Collaborators

Japan Clinical Oncology Group

Ministry of Health, Labour and Welfare, Japan

Investigators

Study Chair:

Yutaka Nishiwaki, MD

National Cancer Center Hospital East

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	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:	February 2, 2009
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
Etoposide phosphate
Irinotecan

Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012