ISRCTN - ISRCTN80153848: 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)

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Ferry

ORCID ID

Contact details

Eli Lilly and Company
Bridgewater
NJ
-
United States of America
-
ferry_david@lilly.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00112710

Protocol/serial number

LU 3005

Study information

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)

Acronym

BTOG2

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Gemcitabine, cisplatin, carboplatin

Primary outcome measure

Length of survival

Secondary outcome measures

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

Overall trial start date

01/04/2005

Overall trial end date

01/04/2008

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1350

Total final enrolment

1363

Participant 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

Recruitment start date

01/04/2005

Recruitment end date

01/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Wolverhampton Hospitals NHS Trust
Wolverhampton
WV10 0QP
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location