| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN76747656 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LIVERPL-HN1 |
| Public title | A Phase II Randomised Study of Cisplatinum and Nifedipine in End Stage Carcinoma of the Head and Neck |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Head and Neck |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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:
a) Mouth
b) Nasopharynx
c) Oropharynx
d) Hypopharynx
e) Larynx
f) Nose and sinuses
g) Middle ear
3. No prior chemotherapy
4. Not suitable for surgery or radiotherapy with a curative purpose
5. Karnofsky performance >50
6. Minimum of 3 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | North West Cancer Research Fund |
| Sponsor details | 22 Oxford Street
Liverpool
United Kingdom
L7 7BL |
| Sponsor telephone | +44 0151709 2919 |
| Sponsor fax | +44 0151 708 7997 |
| Sponsor email | GenSec@cancerresearchnorthwest.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76747656 |
| Date last extracted from ISRCTN register | 17/04/2008 |
