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Radiation therapy using a fractionation modulated according to the pharmacokinetics of Cetuximab in squamous cell carcinoma head and neck cancer patient

SIB –IMRT using a modulated accelerated fractionation for head and neck cancer patients - FAMOSO

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002765-36-IT
Enrollment
Unknown
Registered
2014-01-27
Start date
2014-03-23
Completion date
Unknown
Last updated
2014-06-30

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

Conditions

head and neck squamous cell carcinoma eligible for a curative treatment with radiotherapy and Cetuximab MedDRA version: 16.1 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: Erbitux Product Name: Erbitux Pharmaceutical Form: Solution for infusion

Sponsors

Istituto Europeo di Oncologia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Pazienti con diagnosi istologica di carcinoma squamoso dell’orofaringe, laringe ed ipofaringe con indicazione a trattamento con radioterapia e Cetuximab a scopo curativo - Overespressione di EGFR (>50%) - PS (ECOG) =2 - Pazienti con età > 18 anni - Consenso informato scritto 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Presence of distant metastasis - Oral cavity and nasopharynx tumor - Skin bolus required - Previous treatments on the head and neck region - Collagen disease or severe comorbidities

Design outcomes

Primary

MeasureTime frame
Main Objective: To test the feasibility, in the clinical practice, of a radiation treatment with a time dose modulation ;Secondary Objective: -Evaluation of skin toxicity and comparison with literature data -Evaluation of treatment response rate (Overall Response Rate –ORR) and comparison with literature data ;Primary end point(s): - To test the feasibility, in the clinical practice, of a radiation treatment with a time dose modulation ;Timepoint(s) of evaluation of this end point: 14 months—

Secondary

MeasureTime frame
Secondary end point(s): -Evaluation of skin toxicity and comparison with literature data -Evaluation of treatment response rate (Overall Response Rate –ORR) and comparison with literature data ;Timepoint(s) of evaluation of this end point: 14 months—

Countries

Italy

Contacts

Public ContactUff. Studi Clinici e Att.Regolatori

Istituto Europeo di Oncologia

00390257489848

Outcome results

None listed

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