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
DOI	https://doi.org/10.1186/ISRCTN80153848
ClinicalTrials.gov (NCT)	NCT00112710
Protocol serial number	LU 3005
Sponsor	University of Birmingham
Funder	Cancer Research UK (CRUK)

Submission date: 05/08/2005
Registration date: 09/09/2005
Last edited: 12/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-for-advanced-non-small-cell-lung-cancer

Contact information

Prof David Ferry
Scientific

Eli Lilly and Company
Bridgewater, NJ
-
United States of America

Email	ferry_david@lilly.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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)
Study acronym	BTOG2
Study objectives	To establish the optimal cisplatin dose and whether carboplatin can be effectively substituted for the cisplatin at this dose
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Non-small cell lung cancer
Intervention	Chemotherapy - Gemcitabine plus Cisplatin at 80 mg/m^2 versus Gemcitabine plus Cisplatin at 50 mg/m^2 versus Gemcitabine plus Carboplatin AUC 6
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine, cisplatin, carboplatin
Primary outcome measure(s)	Length of survival
Key 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
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1350
Total final enrolment	1363
Key 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
Key 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
Date of first enrolment	01/04/2005
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton
WV10 0QP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Results article	results	01/09/2017	12/10/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

12/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The CRUK link has been updated in the plain English summary.
4. The scientific contact's details have been updated.
5. The sponsor contact details have been updated.