BTOG2: A British Thoracic Oncology Group phase III trial of gemcitabine plus cisplatin at 80 mg/m2 versus gemcitabine plus cisplatin at 50 mg/m2 versus gemcitabine plus carboplatin AUC 6 in stage IIIB/IV non-small cell lung cancer (NSCLC - BTOG2
- Conditions
- on-small cell lung cancer
- Registration Number
- EUCTR2004-003868-30-IE
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1350
·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 <1.5xULN, Alkaline phosphatase, AST <3.0xULN or <5xULN in the presence of liver metastases
·Patient compliance and geographic proximity that allows adequate follow-up
·Able and willing to participate in the quality of life assessment
·Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
·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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<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<br>6)Costs and cost-effectiveness<br>;Primary end point(s): Length of survival
- Secondary Outcome Measures
Name Time Method