NCT00190476

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

Geographic Reach
1 country

29 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

First QC Date

September 11, 2005

Last Update Submit

September 8, 2016

Conditions

Non-small-cell Lung Cancer

Keywords

Elderlyadvancednon-small-cell lung cancercisplatindocetaxelweeklycombinationchemotherapyrandomized trial

Outcome Measures

Primary Outcomes (1)

  • overall survival

Secondary Outcomes (4)

  • Toxicity

  • Progression-free survival

  • Response rate

  • Symptom score

Interventions

Weekly docetaxel aloneDRUG
Weekly docetaxel + cisplatin combinationDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Symptomatic brain metastasis
  • Active another neoplasms
  • Severe SVC syndrome
  • Massive pericardial, pleural effusion, or ascites
  • Bone metastasis emergent for palliative radiotherapy or surgery
  • Uncontrollable systemic hypertension
  • Heart failure, Unstable angina, Myocardial infarction within 6 months
  • Uncontrollable diabetes
  • Active infection
  • Interstitial pneumonia/ Pulmonary fibrosis
  • Hypersensitivity for polysorbate 80
  • Systemic administration of corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan

Location

Aichi Cancer Center,Aichi Hospital

Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011, Japan

Location

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

Kyushu University Hospital

Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan

Location

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, 500-8323, Japan

Location

Gunma Prefectural Cancer Center

Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550, Japan

Location

National Nishigunma Hospital

Shibukawa,Kanai,2854, Gunma, 377-8511, Japan

Location

National Hospital Organization, Dohoku National Hospital

Asahikawa,Hanasaki,7-4048, Hokkaido, 070-8644, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804, Japan

Location

Hyogo Medical Center for Adults

Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558, Japan

Location

Hyogo College of Medicine

Nishinomiya,Mukogawa-cho,1-1, Hyōgo, 663-8501, Japan

Location

Ibaraki Kenritsu Chuo Hospital & Cancer Center

Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793, Japan

Location

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan

Location

Yokohama Mucipical Citizen's Hospital

Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555, Japan

Location

Kumamoto Regional Medical Center Hospital

Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811, Japan

Location

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho, 2-15-3, Niigata, 951-8566, Japan

Location

Osaka Prefectural Medical Center for Respiratory and Allergic Disease

Habikino,Habikino,3-7-1, Osaka, 583-8588, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan

Location

Osaka City General Hospital

Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021, Japan

Location

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai,Nagasone,1180, Osaka, 591-8555, Japan

Location

National Hospital Organization Toneyama National Hospital

Toyonaka,Toneyama,5-1-1, Osaka, 560-8552, Japan

Location

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan

Location

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777, Japan

Location

Tochigi Cancer Center

Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan

Location

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

Location

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25378648DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Akira Yokoyama, MD, PhD

    Department of Internal Medicine, Niigata Cancer Center Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

April 1, 2003

Study Completion

April 1, 2007

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

JP(29)