ISRCTN ISRCTN15654915
DOI https://doi.org/10.1186/ISRCTN15654915
Protocol serial number TH/SMC
Sponsor Northern and Yorkshire Clinical Trials and Research Unit (UK)
Funder Northern & Yorkshire Clinical Trials & Research Unit (UK)
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
24/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleYorkshire Collaborative Small Cell Lung Cancer Study
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLung (small cell)
InterventionGood/moderate-prognosis patients: Patients receive chemotherapy with Ifosfamide, etoposide, mensa and vincristine (EIMV) for three courses. Patients with greater than 50% response are randomised to either:
1. Group A: No mandatory treatment, radiotherapy is optional.
2. Group B: Three further courses of EIMV chemotherapy plus optional radiotherapy.

Poor-prognosis patients: Chemotherapy is at the physicians discretion. If chemotherapy is chosen single agent etoposide or EIMV chemotherapy is recommended.
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteria1. Small cell lung cancer confirmed by histological or bronchial brush or aspirate cytology.
2. Aged <75 years
3. Normal renal and hepatic function
4. No evidence of brain metastases
5. No previous specific anti-cancer treatment for current disease
6. No other malignant disease, except basal cell carcinoma and in situ carcinoma of the cervix
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1994
Date of final enrolment01/04/1995

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2019: No publications found. All search options exhausted.