Radiotherapy in Association With Cetuximab in Patients Tr... | NCT01647555

Studies
Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer

NCT01647555

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 18, 2026Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Epidermoid Head and Neck Cancer

Interventions

Cetuximab
Radiotherapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2006Actual

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 20, 2012

First Posted Date

Jul 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

Detailed Description

This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with epidermoid cancer		receiving Cetuximab and radiotherapy	Drug: Cetuximab Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	First cycle: 400 mg/m2 Next cycles: 250 mg/m2	patient with epidermoid cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin toxicities	according to NCI-CTCAE version 3.0	until week 38

Secondary Outcomes

Measure	Description	Time Frame
Healthcare and evolution of skin toxicities	Treatment of skin toxicities, according to sponsor advices.	until week 38
Quality of life reporting	Questionnaire QLQ-C30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Epidermoid head and neck carcinoma locally advanced
Indication of Cetuximab and radiotherapy
Karnofsky >= 60
Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer

The radiotherapy will be delivered for curative aim (minimal dose 66 Gy)

Exclusion Criteria:

other histology
Metastatic disease
Recurrent patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with epidermoid head and neck cancer locally advanced

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric LARTIGAU, MD, PhD	Oscar Lambret Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique du Parc		Croix		599962	France
Centre Leonard de Vinci

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068818	Cetuximab
D011878	Radiotherapy

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided