Randomised trial of two schedules of chemotherapy of the same dose/time intensity in untreated small cell lung cancer (SCLC) of poor prognosis
| ISRCTN | ISRCTN92669260 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92669260 |
| Secondary identifying numbers | TR7SCLC |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 24/02/2015
- 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
Not provided at time of registration
Contact information
- - -
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) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial of two schedules of chemotherapy of the same dose/time intensity in untreated small cell lung cancer (SCLC) of poor prognosis |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Lung (small cell) cancer |
| Intervention | 1. Standard Regimen: Multi-drug chemotherapy, cyclophosphamide, adriamycin and vincristine alternating every 21 days with etoposide and cisplatin. A total of six courses, three with each drug combination. 2. Low Dose/High Frequency Regimen: Multi-drug chemotherapy, etoposide and cisplatin alternating every 10/11 days with cyclophosphamide, adriamycin and vincristine. A total of twelve courses, six with each drug combination. This schedule uses the same drugs as in the standard regimen but at half the dose and twice the frequency with the same intended overall dose intensity. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, adriamycin, vincristine, etoposide, cisplatin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Overall study end date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | 1. Histologically or cytologically proven small cell carcinoma of the lung 2. Aged 75 or under 3. Extensive disease and poor prognosis, ie Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3 and/or alkaline phosphatase >1.5 upper limit of normal range 4. Adequate renal function 5. No previous malignancy, except non melanomatous skin cancer in the preceding 3 years 6. No previous chemotherapy or radiotherapy, except for emergency radiotherapy for superior vena cava obstruction 7. No medical contraindications to treatment |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/01/2000 |
| Recruitment end date | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
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
Research organisation
Cancer organisations
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 |
