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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Weekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis |
| 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) cancer |
| Intervention | 1. 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 type | Drug |
| Phase | Not 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 date | 31/12/1992 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1988 |
| Date of final enrolment | 31/12/1992 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Editorial Notes
15/01/2019: No publications found. All search options exhausted.