Elderly NSCLC/D vs DP (JCOG0207)

September 8, 2016 updated by: Japan Clinical Oncology Group

Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.

Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Study Type

Interventional

Enrollment

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. histologically or cytologically proven non-small-cell lung cancer
  2. stage IV, or stage III disease ineligible for definitive radiotherapy
  3. 70 years or older
  4. ECOG PS 0-1
  5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
  6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
  7. No prior surgery within 4 weeks before enrollment
  8. No prior radiotherapy for primary tumor
  9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
  10. Adequate organ function
  11. Signed informed consent

Exclusion Criteria:

  1. Symptomatic brain metastasis
  2. Active another neoplasms
  3. Severe SVC syndrome
  4. Massive pericardial, pleural effusion, or ascites
  5. Bone metastasis emergent for palliative radiotherapy or surgery
  6. Uncontrollable systemic hypertension
  7. Heart failure, Unstable angina, Myocardial infarction within 6 months
  8. Uncontrollable diabetes
  9. Active infection
  10. Interstitial pneumonia/ Pulmonary fibrosis
  11. Hypersensitivity for polysorbate 80
  12. Systemic administration of corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
overall survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Response rate
Progression-free survival
Symptom score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Akira Yokoyama, MD, PhD, Department of Internal Medicine, Niigata Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

April 1, 2007

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0207
  • C000000146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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