HX4 in Head and Neck Cancer.

Phase 1

• Conditions: Patients with histological or cytological confirmed squamous cell carcinomas of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0; MedDRA version: 14.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001812-80-NL
• Lead Sponsor: Maastro Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-14
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
- Tumor (or lymph node) diameter = 2,5 cm
- WHO performance status 0 to 2
- Scheduled for primary curative (concurrent chemo-) radiotherapy
- No previous surgery to the head and neck
- No previous radiation to the head and neck
- Adequate renal function (calculated creatinine clearance at least 60 ml/min)
- The patient is willing and capable to comply with study procedures
- 18 years or older
- Have given written informed consent before patien registration

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

No recent (< 3 months) myocardial infarction
- No Uncontrolled infectious disease
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified