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:	Japanese Ministry of Health, Labor and Welfare
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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
1: Active Comparator Etoposide and cisplatin after chemoradiotherapy	Drug: Etoposide and cisplatin after chemoradiotherapy Etoposide and cisplatin after chemoradiotherapy
2: Experimental 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

Show 37 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

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 ( Japan Clinical Oncology Group )
Study ID Numbers:	JCOG0202-MF, C000000095
Study First Received:	September 1, 2005
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00144989 History of Changes
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:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Irinotecan
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009