A British Thoracic Oncology Group phase III trial of Gemcitabine plus Cisplatin at 80 mg/m^2 versus Gemcitabine plus Cisplatin at 50 mg/m^2 versus Gemcitabine plus Carboplatin area under the concentration-time curve (AUC) 6 in stage IIIB/IV non-small cell lung cancer (NSCLC)
- Conditions
- on-small cell lung cancerCancerNon-small cell lung cancer
- Registration Number
- ISRCTN80153848
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
2011 results in http://thorax.bmj.com/content/66/Suppl_4/A41.1 2017 results in https://pubmed.ncbi.nlm.nih.gov/28780466/ (added 12/10/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1363
1. Histologically or cytologically confirmed NSCLC (excluding mixed SCLC/NSCLC)
2. Radiologically verified stage IIIB (unsuitable for radical radiotherapy) or stage IV disease
3. Presence of one or more clinically or radiological measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
4. World Health Organisation (WHO) Performance status zero, one or two
5. Aged over 18 years
6. Life expectancy more than 12 weeks
7. Adequate haematological function and hepatobiliary function
8. Creatinine clearance: 60 ml/min or 70 ml/min (51Cr-EDTA)
9. Able to participate in the quality of life assessment
10. Written informed consent
1. Prior chemotherapy or radiotherapy (prior surgical resection is allowed)
2. Evidence of severe or uncontrolled systemic diseases
3. Evidence of significant clinical disorder or laboratory finding
4. Concomitant or previous malignancy likely to interfere with protocol treatment or comparisons
5. Pre-existing neuropathy grade more than two
6. Clinically apparent metastatic disease to brain
7. Unresolved toxicity or incomplete recovery from previous surgery
8. Psychiatric disorder making informed consent impossible or preventing completion of treatment or follow-up
9. Previous investigational agent in the last 12 weeks
10. Male and female patients (of childbearing age) not using adequate contraception
11. Female patients who are pregnant or breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ength of survival
- Secondary Outcome Measures
Name Time Method <br> 1. Symptom control and quality of life<br> 2. Response to treatment<br> 3. Dose intensity of chemotherapy<br> 4. Ratio of cycles given as in-patient versus out-patient<br> 5. Intensity, number and duration of toxic episodes (grade two to four)<br> 6. Costs<br> 7. Proteomic and genomic<br>