- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00738868
Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.
Secondary
- Determine the incidence of cutaneous toxicity.
- Assess the care and development of skin reactions.
- Determine the quality of life of patients treated with this drug.
- Determine tumor response at 2 months.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.
After completion of study therapy, patients are followed at 2 months and then every 3 months for 2 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Lille, Frankrig, 59020
- Centre Oscar Lambret
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Eric Lartigau, MD, PhD, Centre Oscar Lambret
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III planocellulært karcinom i læben og mundhulen
- stadium III verrucous carcinom i mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- tilbagevendende verrucous carcinom i mundhulen
- stadium III planocellulært karcinom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- stadium III planocellulært karcinom i nasopharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- stadium III planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- stadium III verrucous carcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- tilbagevendende verrucous carcinom i strubehovedet
- stadium III planocellulært karcinom i paranasale sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- tilbagevendende spytkirtelkræft
- stadium III spytkirtelkræft
- spytkirtel planocellulært karcinom
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000589673
- COL-CKNO-RERT
- COL-0705
- INCA-RECF0629
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med cetuximab
-
University Medical Center GroningenUMC Utrecht; Erasmus Medical CenterRekrutteringPlanocellulært karcinom i hoved og hals | MarginvurderingHolland
-
Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center GroningenAfsluttetMetastatisk tyktarmskræftHolland
-
West China HospitalFirst Affiliated Hospital of Chongqing Medical UniversityRekrutteringColo-rektal cancer | Capecitabin | CetuximabKina
-
Eben RosenthalNational Cancer Institute (NCI)AfsluttetAdenocarcinom i bugspytkirtlenForenede Stater
-
HiberCell, Inc.AfsluttetKolorektal cancerForenede Stater, Puerto Rico, Tyskland, Frankrig
-
Merck KGaA, Darmstadt, GermanyAfsluttetTidligere ubehandlet metastatisk tyktarmskræftFrankrig, Italien, Polen, Tyskland, Hong Kong, Østrig, Brasilien, Israel, Grækenland, Argentina, Thailand, Belgien, Australien, Mexico
-
Arbeitsgemeinschaft medikamentoese TumortherapieMerck Sharp & Dohme LLCAfsluttet
-
Gruppo Oncologico del Nord-OvestAfsluttetMetastatisk tyktarmskræftItalien
-
Cancer Institute and Hospital, Chinese Academy...Rekruttering
-
Poitiers University HospitalAfsluttetUndersøgelse af hudtoksicitet af Cetuximab: Find en forbindelse mellem hudbetændelse og tumorresponsMetastatisk tyktarmskræftFrankrig