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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


Phase 3
20 Years
70 Years
Open (Enrolling)
Both
Small-Cell-Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

during the study conduct

Safety Issue:

No

Principal Investigator

Yutaka Nishiwaki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital East

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0202-MF

NCT ID:

NCT00144989

Start Date:

September 2002

Completion Date:

September 2011

Related Keywords:

  • Small-Cell-Lung Cancer
  • Small-cell lung cancer
  • Limited-Stage Small-Cell Lung Cancer
  • Combined modality therapy
  • chemotherapy
  • radiotherapy
  • Irinotecan
  • Cisplatin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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