Elderly NSCLC/D vs DP (JCOG0207)

NCT ID: NCT00190476

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Weekly docetaxel alone

Intervention Type DRUG

Weekly docetaxel + cisplatin combination

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role collaborator

Japan Clinical Oncology Group

OTHER

Sponsor Role lead

Principal Investigators

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Akira Yokoyama, MD, PhD

Role: STUDY_CHAIR

Department of Internal Medicine, Niigata Cancer Center Hospital

Locations

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Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Site Status

Aichi Cancer Center,Aichi Hospital

Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Site Status

Kyushu University Hospital

Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Site Status

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Site Status

Gunma Prefectural Cancer Center

Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

Site Status

National Nishigunma Hospital

Shibukawa,Kanai,2854, Gunma, Japan

Site Status

National Hospital Organization, Dohoku National Hospital

Asahikawa,Hanasaki,7-4048, Hokkaido, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan

Site Status

Hyogo Medical Center for Adults

Akashi,Kitaouji-cho,13-70, Hyōgo, Japan

Site Status

Hyogo College of Medicine

Nishinomiya,Mukogawa-cho,1-1, Hyōgo, Japan

Site Status

Ibaraki Kenritsu Chuo Hospital & Cancer Center

Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan

Site Status

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Site Status

Yokohama Mucipical Citizen's Hospital

Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan

Site Status

Kumamoto Regional Medical Center Hospital

Kumamoto,Honjo,5-16-10, Kumamoto, Japan

Site Status

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho, 2-15-3, Niigata, Japan

Site Status

Osaka Prefectural Medical Center for Respiratory and Allergic Disease

Habikino,Habikino,3-7-1, Osaka, Japan

Site Status

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Site Status

Osaka City General Hospital

Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan

Site Status

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan

Site Status

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai,Nagasone,1180, Osaka, Japan

Site Status

National Hospital Organization Toneyama National Hospital

Toyonaka,Toneyama,5-1-1, Osaka, Japan

Site Status

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, Japan

Site Status

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan

Site Status

Tochigi Cancer Center

Utsunomiya,Yohnan,4-9-13, Tochigi, Japan

Site Status

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

Site Status

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan

Site Status

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, Japan

Site Status

Countries

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Japan

References

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Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.

Reference Type DERIVED
PMID: 25378648 (View on PubMed)

Related Links

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Other Identifiers

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C000000146

Identifier Type: -

Identifier Source: secondary_id

JCOG0207

Identifier Type: -

Identifier Source: org_study_id

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