A randomised study of oral versus intravenous chemotherapy in poor prognosis small cell lung cancer (SCLC)
| ISRCTN | ISRCTN73797340 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73797340 |
| Secondary identifying numbers | TR9SCLC |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 13/06/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lung (small cell) |
| Intervention | 1. Regimen A: Chemotherapy, oral etoposide repeated every 3 weeks for six courses. 2. Regimen B: Multi-drug chemotherapy, CAV (cyclophosphamide, adriamycin, vincristine) alternating every 3 weeks with PE (etoposide, cisplatin). A total of six courses, three with each drug combination. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1997 |
| Completion date | 31/12/2000 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Histologically or cytologically proven SCLC 2. Patients with extensive disease and poor prognosis, i.e., Eastern Cooperative Oncology Group (ECOG) performance 2 or 3 or alkaline phosphatase >1.5 upper limit normal range 3. Patients 75 years and over, whatever stage of disease, deemed fit for randomisation 4. No previous malignancy, except non-melanomatous skin cancer in the preceding 3 years 5. No medical contraindications to treatment 6. Adequate renal function |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/08/1996 | Yes | No |
