- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00824785
REAL3 Trial of Efficacy of EOX With/Without Panitumumab in Previously Untreated Adv OG Cancer (REAL3)
10 december 2012 uppdaterad av: Professor David Cunningham, Royal Marsden NHS Foundation Trust
REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer
To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Multicentre phase III, open labelled, randomised controlled trial.
Randomisation will be 1:1 Arm A EOX and Arm B EOX + panitumumab.
There will be a pilot phase II study of which the first 200 patients will be randomised and the primary endpoint for interim analysis will be when these patients have completed 6 months follow-up
Studietyp
Interventionell
Inskrivning (Faktisk)
574
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Bournemouth, Storbritannien
- Bournemouth
-
Guildford, Storbritannien
- St Luke's Guildford
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Liverpool, Storbritannien
- Royal Liverpool
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London, Storbritannien, SW3 6JJ
- Royal Marsden NHS Foundation Trust
-
Newcastle, Storbritannien
- Newcastle
-
Sutton, Storbritannien
- Royal Marsden NHS Foundation Trust
-
Wirral, Storbritannien
- Clatterbridge Oncology Centre
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Histologically verified inoperable locally advanced or metastatic adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach.
- Slides of tumour tissue should be available for centralised EGFR staining
- Uni-dimensionally measurable disease (CT or MRI as per RECIST).
- No prior chemotherapy including previous adjuvant chemotherapy
- No prior radiotherapy including adjuvant radiotherapy. Patients receiving palliative radiotherapy to sites of disease that are not measurable may be eligible and should be discussed with the Chief Investigator.
- Male/female patients aged ≥18 years.
- WHO Performance status 0, 1 or 2.
- Patients should have a projected life expectancy of at least 3 months.
- Completion of baseline quality of life questionnaire (EORTC QLQ C30).
- Adequate cardiac function; formal measurement of left ventricular ejection fraction is only required if clinically indicated.
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5x109/l; white blood cell count ≥ 3x109/l; platelets ≥ 100x109/l; haemoglobin (Hb) ≥ 9g/dl (can be post-transfusion).
- Adequate renal function: calculated creatinine clearance ≥50ml/minute.
- Adequate liver function: serum bilirubin ≤1.5x ULN; ALT/AST ≤2.5x ULN; ALP ≤3x ULN (in the absence of liver metastases). If liver metastases are present, serum transaminases ≤5x ULN are permitted.
- Written informed consent must be obtained from the patient before any study-specific procedures are performed (see Section 12.0).
Note: Epidermal growth factor receptor (EGFR) positivity by immunohistochemistry will not be required for study entry. Slides obtained from previously collected paraffin embedded archived specimens will be collected centrally for EGFR staining. A multivariate analysis will then be performed to exclude any effects of EGFR status on outcome measures
Exclusion Criteria:
- Tumours of squamous histology.
- Patients with locally advanced oesophageal cancer suitable for definitive chemoradiotherapy.
- Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- Previous chemotherapy or radiotherapy. See Inclusion criteria for note regarding palliative radiotherapy.
- Any major surgery within 4 weeks prior to the start of study treatment.
- Any prior treatment with an EGFR signal transduction directed therapy.
- Treatment with non-permitted medication.
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, uncontrolled cardiac dysrhythmia, or myocardial infarction within the last 12 months. Patients with any history of clinically significant cardiac failure are excluded from study entry.
- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
- Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
- Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication (administration of capecitabine by naso-gastric or jejunostomy feeding tube is permitted).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known hypersensitivity to panitumumab, components of the EOX regimen, or any of the constituents of these agents.
- Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection.
- Other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial.
- Female patients who may be pregnant or breastfeeding. Potential female patients of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation, or have had amenorrhea for more than 2 years.
- Patients of child-bearing potential not consenting to use adequate contraceptive precautions or abstinence during the course of the study and for 6 months after the last study drug administration for females, and 1 month for males.
- Any other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
- Treatment with another investigational agent within 30 days of commencing study treatment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm A EOX
EOX chemotherapy (epirubicin, oxaliplatin and capecitabine)
|
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21
|
Aktiv komparator: Arm B EOX + panitumumab.
EOX chemotherapy with the addition of panitumumab 9mg/kg every 21 days
|
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 100mg/m(2) IV on day 1 with hydration capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 panitumumab -9 mg/kg every 21 days
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall survival
Tidsram: Early termination
|
Study closed early due to lack of efficacy
|
Early termination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
response rate, toxicity, quality of life and PFS
Tidsram: Early termination
|
Study closed early due to lack of efficacy
|
Early termination
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Prof Cunningham, David, Royal Marsden NHS Foundation Trust
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Smyth EC, Vlachogiannis G, Hedayat S, Harbery A, Hulkki-Wilson S, Salati M, Kouvelakis K, Fernandez-Mateos J, Cresswell GD, Fontana E, Seidlitz T, Peckitt C, Hahne JC, Lampis A, Begum R, Watkins D, Rao S, Starling N, Waddell T, Okines A, Crosby T, Mansoor W, Wadsley J, Middleton G, Fassan M, Wotherspoon A, Braconi C, Chau I, Vivanco I, Sottoriva A, Stange DE, Cunningham D, Valeri N. EGFR amplification and outcome in a randomised phase III trial of chemotherapy alone or chemotherapy plus panitumumab for advanced gastro-oesophageal cancers. Gut. 2021 Sep;70(9):1632-1641. doi: 10.1136/gutjnl-2020-322658. Epub 2020 Nov 16.
- Waddell T, Chau I, Cunningham D, Gonzalez D, Okines AF, Okines C, Wotherspoon A, Saffery C, Middleton G, Wadsley J, Ferry D, Mansoor W, Crosby T, Coxon F, Smith D, Waters J, Iveson T, Falk S, Slater S, Peckitt C, Barbachano Y. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol. 2013 May;14(6):481-9. doi: 10.1016/S1470-2045(13)70096-2. Epub 2013 Apr 15. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254. Frances, Alicia [corrected to Okines, Alicia Frances Clare].
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2008
Primärt slutförande (Förväntat)
1 februari 2013
Avslutad studie (Förväntat)
1 februari 2013
Studieregistreringsdatum
Först inskickad
16 januari 2009
Först inskickad som uppfyllde QC-kriterierna
16 januari 2009
Första postat (Uppskatta)
19 januari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 december 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 december 2012
Senast verifierad
1 december 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i magen
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antineoplastiska medel, immunologiska
- Antibiotika, antineoplastiska
- Capecitabin
- Epirubicin
- Oxaliplatin
- Panitumumab
Andra studie-ID-nummer
- CCR3024
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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