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Comparison of two concomitant administration of radiotherapy with cisplatin in standard infusion (1 time every 21 days) or fractional infusion ( 4 times every 21 days)

Phase II randomized trial comparating two concomitant administration of radiotherapy with cisplatin in patients with not operated or inoperable squamous cell carcinoma of the head and neck or with recurrence high-risk in adjuvant postoperative treatment. - CisFRad

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-001928-29-FR
Enrollment
92
Registered
2015-07-23
Start date
2015-07-07
Completion date
Unknown
Last updated
2021-10-08

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

Conditions

MedDRA version: 18.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cisplatine Accord Product Name: CISPLATINE Pharmaceutical Form: Solution for infusion INN or Proposed INN: CISPLATINE Other descriptive name: CISPLATIN Trade Name: CISPLATINE ACCORD Produ

Sponsors

GORTEC
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 92

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

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

Countries

France

Contacts

Public ContactMarie-Hélène GIRARD CALAIS

GORTEC

rc.corad@chu-tours.fr33(0)2 47 47 91 21

Outcome results

None listed

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