Weekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis

ISRCTN ISRCTN26181691
DOI https://doi.org/10.1186/ISRCTN26181691
Secondary identifying numbers TR6SCLC
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
15/01/2019
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleWeekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis
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) cancer
Intervention1. Intensive Regimen: Chemotherapy, cisplatin and etoposide alternating every 7 days with ifosfamide and adriamycin. A total of twelve courses, six with each drug combination.
2. Standard Regimen: Chemotherapy, cisplatin and etoposide alternating every 21 days with ifosfamide and adriamycin. A total of six courses, three with each drug combination.

All limited disease patients who show complete or partial response following chemotherapy receive thoracic irradiation.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Cisplatin, etoposide, ifosfamide, adriamycin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1988
Completion date31/12/1992

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Histologically or cytologically proven SCLC
2. Age 75 or under
3. Either limited disease or extensive disease in the good prognostic category. That is have both of the following characteristics, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and alkaline phosphatase <1.5 upper limit of normal range
4. Adequate renal function
5. No previous malignancy, except non-melanomatous skin cancer
6. No previous chemotherapy or radiotherapy
7. No medical contraindications to treatment
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1988
Date of final enrolment31/12/1992

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

Editorial Notes

15/01/2019: No publications found. All search options exhausted.