Elderly NSCLC/D vs DP (JCOG0207)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190476
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 12, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination Phase 3

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  (Clinical Trial)
Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
Study Start Date : April 2003
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. Toxicity
  2. Progression-free survival
  3. Response rate
  4. Symptom score

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190476

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00190476     History of Changes
Other Study ID Numbers: JCOG0207
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016

Keywords provided by Japan Clinical Oncology Group:
non-small-cell lung cancer
randomized trial

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action