squamous cell carcinoma of the lung
Conditions
Interventions
Nedaplatin at 100mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered.
Cisplat
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cytologically or histologically documented squamous cell carcinoma of the lung. Non-small-cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component are also acceptable. 2)Clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy. 3)Patient must have received no prior chemotherapy. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 1 year prior to recurrence of the disease. 4)ECOG performance status of 0 or 1. 5)>=20 and <75 years of age. 6)Radiographically-documented evaluable disease. Both measurable and non-measurable disease are permitted. 7)Expected survival of >= 3 months. 8)Adequate organ function. 9)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Symptomatic brain metastasis or brain metastasis which needs treatment like adrenal corticosteroids or antiepileptic drugs. 2)Other current active malignancy. 3)Superior vena cava syndrome. 4)Malignant pericardial/ pleural/ peritoneal effusion which need continuous drainage or rapidly increase after temporary drainage. 5)Patient has received radiotherapy to the primary lesion. 6)Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 7)Patient has a clinically significant con current illness. 8)Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray. 9)Pregnant or breast-feeding woman or patient who doesn't agree to contraception. 10)Patient has a history of severe allergy or hypersensitivity. 11)Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, response rate and adverse events | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed