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NCT Number: NCT00144989

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

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.

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Key information

Conditions

Small-Cell-Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etoposide and cisplatin after chemoradiotherapy

Drug

Etoposide and cisplatin after chemoradiotherapy

Irinotecan and cisplatin after chemoradiotherapy

Drug

Irinotecan and cisplatin after chemoradiotherapy

Primary outcomes

  1. overall survival

    Time frame: during the study conduct

Secondary outcomes

  1. adverse events of induction chemoradiotherapy

    Time frame: during the study conduct

  2. chemotherapy after chemoradiotherapy

    Time frame: during the study conduct

  3. late radiation morbidity

    Time frame: during the study conduct

  4. serious adverse event

    Time frame: during the study conduct

  5. progression-free survival

    Time frame: during the study conduct

Sponsors and collaborators

Lead sponsor

Haruhiko Fukuda

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Sep 5, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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