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
Protocol serial number TR6SCLC
Sponsor Cancer Research UK (CRUK) (UK)
Funder Cancer Research UK
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
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
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Cisplatin, etoposide, ifosfamide, adriamycin
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/1992

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
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

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Editorial Notes

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