deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00144989

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

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

Sponsor: Haruhiko Fukuda

Conditions Small-Cell-Lung Cancer
Interventions Etoposide and cisplatin after chemoradiotherapy Irinotecan and cisplatin after chemoradiotherapy
Updated 6 times since 2017 Last updated: Sep 20, 2016 Started: Sep 30, 2002 Primary completion: Sep 30, 2011 Completion: Sep 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00144989, this PHASE3 trial focuses on Small-Cell-Lung Cancer and remains completed. Sponsored by Haruhiko Fukuda, it has been updated 6 times since 2002, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 1 earlier version

  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Sep 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Haruhiko Fukuda
  • Ministry of Health, Labour and Welfare, Japan
Data source: Japan Clinical Oncology Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akashi,Kitaouji-cho,13-70, Japan , Asahikawa,Hanasaki,7-4048, Japan , Chuo-ku,Tsukiji,5-1-1, Japan , Gifu,Kashima-cho,7-1, Japan , Habikino,Habikino,3-7-1, Japan , Higashi-ku,Maidashi,3-1-1, Japan , Izumisano,rinku-ohrai-kita,2-23, Japan , Kashiwa-shi,Kashiwanoha,6-5-1, Japan , Kita-adachi,Ina,Komuro,818, Japan , Kobe,Chuo-ku,Minatojimanakamachi,4-6, Japan and 27 more locations