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RANDOMIZED STUDY WITH POSTOPERATIVE RADIOTHERAPY AND CONCURRENT LOW DOSE CISPLATIN VS RADIOTHERAPY AND CONCURRENT CISPLATIN + FLUOROURACIL IN OPERATED HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD & NECK

RANDOMIZED STUDY WITH POSTOPERATIVE RADIOTHERAPY AND CONCURRENT LOW DOSE CISPLATIN VS RADIOTHERAPY AND CONCURRENT CISPLATIN + FLUOROURACIL IN OPERATED HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD & NECK

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000833-39-IT
Enrollment
357
Registered
2008-10-13
Start date
2004-10-22
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Head and neck cancer MedDRA version: 9.1 Level: LLT Classification code 10061325 Term: Oral neoplasm

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: CISPLATINO CAS Number: 15663-27-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-

Sponsors

ISTITUTO NAZIONALE PER LA CURA TUMORI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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