- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00468169
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer (EPIC)
20. september 2019 opdateret af: University of Chicago
A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
110
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18 or older
- Stage III and IV head and neck cancer
- Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
- No prior chemotherapy or radiotherapy
- Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Normal organ and marrow function
Exclusion Criteria:
- Unequivocal demonstration of metastatic disease
- Known severe hypersensitivity to drugs used in the study
- Treatment with a non-approved or investigational drug within 30 days before Day 1
- Incomplete healing from previous surgery
- Pregnancy or breast feeding
- Uncontrolled intercurrent illness including
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
- Acute hepatitis or known HIV
- Severe baseline neurologic deficits
- Prior therapy which specifically and directly targets the EGFR pathway
- Prior severe infusion reaction to a monoclonal antibody
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A: Cetuximab+FHX
Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]).
Total duration is 10 weeks.
|
250mg/m2(day 1, weekly x 10);
Andre navne:
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
500 mg PO BID, days 0-5 every other week x 5
150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
|
Eksperimentel: B: Cetuximab + PX
Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]).
Total duration: 7 weeks.
|
250mg/m2(day 1, weekly x 10);
Andre navne:
100 mg/m2, week 1 and 4 on day 1 (or 2)
72 Gy/42 F/6 W (3-D or IMRT based).
Total duration 7 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival (PFS)
Tidsramme: 1 years
|
Kaplan-Meier estimate of PFS at 1 years.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
1 years
|
Progression Free Survival (PFS)
Tidsramme: 2 years
|
Time from randomization until disease progression or death from any cause.
Kaplan-Meier estimate of PFS at 2 years.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival (OS)
Tidsramme: 2 years
|
Time from randomization until death from any cause.
Kaplan-Meier estimate of OS at 2 years.
|
2 years
|
Objective Response Rate to Induction
Tidsramme: Post-Induction (8 weeks)
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
|
Post-Induction (8 weeks)
|
Objective Response Rate to CRT
Tidsramme: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
|
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
|
From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
|
Residual Lymph Node Disease
Tidsramme: Up to 10 weeks
|
Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.
|
Up to 10 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Everett E Vokes, MD, University of Chicago
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2006
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
30. april 2007
Først indsendt, der opfyldte QC-kriterier
1. maj 2007
Først opslået (Skøn)
2. maj 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14401A
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
-
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
-
Copenhagen University Hospital at HerlevUkendt