Elderly NSCLC/D vs DP (JCOG0207)
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| ClinicalTrials.gov Identifier: NCT00190476 |
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Recruitment Status :
Terminated
First Posted : September 19, 2005
Last Update Posted : September 12, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small-cell Lung Cancer | Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination | Phase 3 |
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 |
- overall survival
- Toxicity
- Progression-free survival
- Response rate
- Symptom score
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| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically or cytologically proven non-small-cell lung cancer
- stage IV, or stage III disease ineligible for definitive radiotherapy
- 70 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
Exclusion Criteria:
- 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
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
Show 29 study locations
| Study Chair: | Akira Yokoyama, MD, PhD | Department of Internal Medicine, Niigata Cancer Center Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Elderly advanced non-small-cell lung cancer cisplatin docetaxel |
weekly combination chemotherapy randomized trial |
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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 |