Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 230
- Locations
- 29
- Primary Endpoint
- overall survival
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
overall survival
Secondary Outcomes
- Progression-free survival
- Response rate
- Symptom score
- Toxicity