Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
16/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study 11

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Condition

Lung (non-small cell) cancer

Intervention

1. GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day 1)

2. MIC 3-Weekly regimen: Mitomycin 6 mg/m2 IV (Day 1) Ifosfamide 3 g/m2 IV (Day 1) Cisplatin 50 mg/m2 IV (Day 1)

Intervention type

Drug

Phase

Phase III

Drug names

Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

31/08/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven non-small cell carcinoma of the lung
2. Stage IIIb or IV disease
3. Measurable or evaluable disease
4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min)
5. Age 18 or over
6. Adequate contraception in females of child-bearing potential
7. Written informed consent
8. No prior radiotherapy or chemotherapy
9. Not less than 8 weeks life expectancy
10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more)
11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL
12. No symptomatic brain metastases

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1995

Recruitment end date

31/08/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

London Lung Cancer Group (UK)

Sponsor details

-
London
-
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

London Lung Cancer Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15625369

Publication citations

  1. Results

    Rudd RM, Gower NH, Spiro SG, Eisen TG, Harper PG, Littler JA, Hatton M, Johnson PW, Martin WM, Rankin EM, James LE, Gregory WM, Qian W, Lee SM, Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group., J. Clin. Oncol., 2005, 23, 1, 142-153, doi: 10.1200/JCO.2005.03.037.

Additional files

Editorial Notes