Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0063072220
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to compare the response rate, time to progression and the survival of patients randomised either to receive Gemcitabine with Carboplatin or MVP/MIC.
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Non small cell lung cancer
Intervention
Randomised, phase III, comparative trial.
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine with Carboplatin versus Mitomycin, Vinblastine and Cisplatin (MVP) or Mitomycin C, Ifosfamide and Cisplatin (MIC)
Primary outcome measure
survival
Secondary outcome measures
1. time to progression
2. response rates
3. evaluation of toxicity
4. disease-related symptoms
5. World Health Organization performance status
6. quality of life
Overall trial start date
01/04/1998
Overall trial end date
01/11/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. NHS patients with pathologically confirmed NSCLC, stage IIIa, IIIb, or IV
2. ineligible for curative radical radiotherapy or surgery after discussion in a multidisciplinary team setting comprised of at least a chest physician, a surgeon, and an oncologist
3. no previous chemotherapy
4. age older than 18 years
5. life expectancy of at least 12 weeks
6. adequate bone marrow reserve (leukocyte count > 3 × 10^9/L, platelet count > 100 × 10^9/L, and hemoglobin > 100 g/dL)
7. creatinine clearance > 60 mL/minute
8. adequate birth-control measures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
660 targeted, 372 recruited
Participant exclusion criteria
1. active infection
2. bony disease as the only measurable disease
3. prior radiotherapy to the sole site of assessable disease
4. inadequate renal or hepatic function
5. serious comorbidity
6. other malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
7. peripheral neuropathy Grade > 2
8. significant neurologic or psychiatric disorder
9. symptomatic brain metastases
Recruitment start date
01/04/1998
Recruitment end date
01/11/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Oncology
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Christie Hospital NHS Trust (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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12879472
Publication citations
-
Results
Danson S, Middleton MR, O'Byrne KJ, Clemons M, Ranson M, Hassan J, Anderson H, Burt PA, Fairve-Finn C, Stout R, Dowd I, Ashcroft L, Beresford C, Thatcher N, Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma., Cancer, 2003, 98, 3, 542-553, doi: 10.1002/cncr.11535.