A phase II randomised study of cisplatinum and nifedipine in end stage carcinoma of the head and neck
| ISRCTN | ISRCTN76747656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76747656 |
| Protocol serial number | LIVERPL-HN1 |
| Sponsor | North West Cancer Research Fund (UK) |
| Funder | Not provided at time of registration |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 10/03/2015
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A phase II randomised study of cisplatinum and nifedipine in end stage carcinoma of the head and neck |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Head and neck cancer |
| Intervention | Patients are randomised to one of two treatment regimens: 1. Group A: Cisplatinum repeated every 21 days for a maximum of six cycles 2. Group B: Cisplatinum plus nifedipine repeated every 21 days for a maximum of six cycles |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cisplatinum and nifedipine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. Patients with either advanced squamous cell carcinoma of the head and neck, not previously treated, or recurrent squamous cell carcinoma of the head and neck after previous radiotherapy or surgery 2. Measurable histologically confirmed, squamous cell carcinoma of the head and neck. The primary sites will be: 2.1. Mouth 2.2. Nasopharynx 2.3. Oropharynx 2.4. Hypopharynx 2.5. Larynx 2.6. Nose and sinuses 2.7. Middle ear 3. No prior chemotherapy 4. Not suitable for surgery or radiotherapy with a curative purpose 5. Karnofsky performance greater than 50 6. Minimum of three weeks since prior radiotherapy and or surgery and patients must have fully recovered from such prior treatments 7. Adequate bone marrow and renal function 8. No active infection 9. No concomitant or prior malignancy except adequately treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2004 |
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 | Not provided at time of registration |
| IPD sharing plan |
