Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr N Thatcher

ORCID ID

Contact details

Medical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3749

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12879472

Publication citations

  1. 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.

Additional files

Editorial Notes