Clinical trial · Interventional
Elderly NSCLC/D vs DP (JCOG0207)
Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
NCT00190476CI-TRIAL-00023831terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weekly docetaxel alone | Drug | — | UNRESOLVED |
| Weekly docetaxel + cisplatin combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- overall survival
Secondary outcomes (4)
- measure
- Toxicity
- measure
- Progression-free survival
- measure
- Response rate
- measure
- Symptom score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTsukada 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 25378648