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

ISRCTN ISRCTN38657696
DOI https://doi.org/10.1186/ISRCTN38657696
Secondary identifying numbers LU3002
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
30/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleMitomycin, 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
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLung (non-small cell) cancer
Intervention1. 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 typeMixed
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date01/01/1996

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment01/01/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article presumed results 01/10/1999 30/10/2019 Yes No

Editorial Notes

30/10/2019: Publication reference added.