NCT00738868

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

July 1, 2009

Enrollment Period

3.6 years

First QC Date

August 20, 2008

Last Update Submit

May 12, 2011

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavityrecurrent verrucous carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavityrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancersalivary gland squamous cell carcinomastage III salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria

Interventions

cetuximabBIOLOGICAL
stereotactic body radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Unresectable disease * Recurrent disease * No metastatic disease * Disease in previously irradiated area must be proven by biopsy or imaging * At least 3 months between prior radiotherapy and diagnosis of recurrent disease * Surgery or brachytherapy must be possible * Measurable or evaluable disease by RECIST criteria * No available curative therapy PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Not pregnant or nursing * No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible * No other malignant disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation in another clinical study of an experimental drug

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

CetuximabRadiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsRadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Eric Lartigau, MD, PhD

    Centre Oscar Lambret

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2011

Last Updated

May 13, 2011

Record last verified: 2009-07

Locations

FR(1)