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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76747656
Enrollment
Unknown
Registered
2002-08-19
Start date
2003-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer Malignant neoplasm of other and ill-defined sites

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

Sponsors

North West Cancer Research Fund (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026