Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

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

LU3002

Study information

Scientific title

Mitomycin, ifosfamide and cisplatin in non-small cell lung cancer (NSCLC): a randomised trial of chemotherapy versus symptomatic treatment only in patients not suitable for radical radiotherapy

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lung (non-small cell) cancer

Intervention

1. Schedule A: Combination chemotherapy, four, 3 weekly cycles of mitomycin, ifosfamide and cisplatin (MIC). Radiotherapy may be given to patients whose symptoms are not responding to the systemic therapy (in this case chemotherapy should be stopped), and to patients developing symptoms after chemotherapy has stopped. Short and simple radiotherapy schedules of one to ten fractions, not exceeding a total dose of 30 Gy should be given.

2. Schedule B: Palliative care only. Radiotherapy should be used where appropriate. Short and simple schedules of one to ten fractions, not exceeding a total dose of 30 Gy.

Intervention type

Mixed

Phase

Drug names

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

01/01/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 75 years or under
2. Histologically or cytologically proven non-small cell lung cancer, ie adeno-squamous or large cell carcinoma
3. Clinically or radiologically evaluable disease
4. Inoperable, but clinically limited stage disease
5. World Health Organisation (WHO) performance status of 0-2
6. No previous chemotherapy or radiotherapy
7. No cerebral metastases, spinal cord compression or symptomatic superior vena cava obstruction
8. Normal renal function
9. No other previous or concurrent malignancy, except cone biopsied carcinoma in-situ of the cervix and adequately treated basal cell carcinoma of the skin
10. No indication that protocol treatment would exacerbate a serious pre-existing medical condition

Participant type

Patient

Age group

Mixed

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

01/01/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes