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
Secondary identifying numbers LIVERPL-HN1
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA phase II randomised study of cisplatinum and nifedipine in end stage carcinoma of the head and neck
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHead and neck cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Cisplatinum and nifedipine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

North West Cancer Research Fund (UK)
Research organisation

22 Oxford Street
Liverpool
L7 7BL
United Kingdom

Phone +44 (0)151709 2919
Email GenSec@cancerresearchnorthwest.co.uk
ROR logo "ROR" https://ror.org/025qv0671

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan