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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.
 
ClinicalTrials.gov Identifier: NCT00190476
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
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.

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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
Drug Information available for: Docetaxel




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   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00190476


Locations
Show Show 29 study locations
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Akira Yokoyama, MD, PhD Department of Internal Medicine, Niigata Cancer Center Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00190476    
Other Study ID Numbers: JCOG0207
C000000146
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:
Elderly
advanced
non-small-cell lung cancer
cisplatin
docetaxel
weekly
combination
chemotherapy
randomized trial
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action