Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
10/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LIVERPL-HN1

Study information

Scientific title

A phase II randomised study of cisplatinum and nifedipine in end stage carcinoma of the head and neck

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Cisplatinum and nifedipine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

North West Cancer Research Fund (UK)

Sponsor details

22 Oxford Street
Liverpool
L7 7BL
United Kingdom
+44 (0)151709 2919
GenSec@cancerresearchnorthwest.co.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes