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21 November 2008
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| [ Print-friendly version ] |
| 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) |
| ISRCTN | ISRCTN80153848 |
| ClinicalTrials.gov identifier | |
| Public title | 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) |
| Scientific title | |
| Acronym | BTOG-2 |
| Serial number at source | LU 3005 |
| Study hypothesis | To establish the optimal cisplatin dose and whether carboplatin can be effectively substituted for the cisplatin at this dose |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Non-small cell lung cancer |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/04/2005 |
| Anticipated end date | 01/04/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1350 |
| Interventions | Chemotherapy - Gemcitabine plus Cisplatin at 80 mg/m^2 versus Gemcitabine plus Cisplatin at 50 mg/m^2 versus Gemcitabine plus Carboplatin AUC 6 |
| Primary outcome measure(s) | Length of survival |
| Secondary outcome measure(s) |
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 (grade two to four) 6. Costs 7. Proteomic and genomic |
| Sources of funding | Cancer Research UK (CRUK) |
| Trial website | |
| Publications | |
| Contact name | Prof David Ferry |
| Address |
Royal Wolverhampton Hospitals NHS Trust
Wednesfield Road |
| City/town | Wolverhampton |
| Zip/Postcode | WV10 0QP |
| Country | United Kingdom |
| Tel | +44 (0)1902 695204 |
| drf@ferryd.freeserve.co.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
Finance Office
Institute for Cancer Studies Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 7618 |
| b.w.laverty@bham.ac.uk | |
| Date applied | 05/08/2005 |
| Last edited | 06/08/2007 |
| Date ISRCTN assigned | 09/09/2005 |
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