Non-small cell lung cancer
Conditions
Interventions
Trade Name: Cisplatin
Product Name: Cisplatin
Pharmaceutical Form: Solution for infusion
Trade Name: Gemcitabine
Product Name: Gemcitabine
Pharmaceutical Form: Powder for injection*
Trade Name: Carb
Sponsors
University of Birmingham
Royal Wolverhampton Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Histologically or cytologically confirmed NSCLC (excluding mixed SCLC/NSCLC) · Radiologically verified stage IIIB (unsuitable for radical radiotherapy) or stage IV disease (see Appendix 4) · Presence of 1 or more clinically or radiological measurable lesions by RECIST criteria (see Appendix 8) · Performance status 0, 1 or 2 (WHO performance scale – see Appendix 5) · Age >18 years · Life expectancy >12 weeks · Adequate haematological function: haemoglobin *10g/dl; WBC *3.0 x 109/L; absolute neutrophil count (ANC) *1.5 x 109/L; platelet count *100,000/mm3 · Creatinine clearance: >60ml/min (Wright, see Appendix 6) or >70ml/min (51Cr-EDTA) · Hepatobiliary function: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Prior chemotherapy or radiotherapy, however prior surgical resection is allowed, provided no neoadjuvant or adjuvant chemotherapy was given · Evidence of severe or uncontrolled systemic diseases that in the view of the investigator, makes it undesirable for the patient to participate in the trial · Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial · Concomitant or previously malignancy likely to interfere with protocol treatment or comparisons · Pre-existing neuropathy grade >2 · Clinical apparent metastatic disease to brain · Unresolved toxicity or incomplete recovery from previous surgery · Psychiatric disorder making reliable informed consent impossible or that might prevent completion of treatment or follow-up · Previous investigational agent in the last 12 weeks · Male and female patients (of childbearing age) not using adequate contraception · Female patients who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy in terms of survival time of gemcitabine plus cisplatin at 80mg/m2 versus gemcitabine plus cisplatin at 50mg/m2 versus gemcitabine plus carboplatin AUC 6 (Wright), in patients with advanced NSCLC;Secondary Objective: To compare the efficacy of gemcitabine plus cisplatin at 80mg/m2 versus gemcitabine plus cisplatin at 50mg/m2 versus gemcitabine plus carboplatin in terms of: 1) Symptom control and quality of life 2) Response to treatment 3) Dose intensity of chemotherapy 4) Ratio of cycles given as in-patient versus out-patient 5) Intensity, number and duration of toxic episodes 6) Costs and cost-effectiveness ;Primary end point(s): Length of survival | — |
Countries
Ireland, United Kingdom
Outcome results
None listed