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Oesophago-gastric CancerPhase 3REAL3NCT00824785

REAL3 Trial of Efficacy of EOX With/Without Panitumumab in Previously Untreated Adv OG Cancer

A Phase 3 study testing epirubicin, oxaliplatin, capecitabine (EOX) and EOX + panitumumab in people with Oesophago-gastric Cancer, run by Royal Marsden NHS Foundation Trust at 7 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oesophago-gastric Cancer
What is being tested?
epirubicin, oxaliplatin, capecitabine (EOX) and EOX + panitumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
7 sitesUnited Kingdom
Study dates
May 2008to Feb 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United Kingdom7 sites

  • Bournemouth

    Bournemouth

  • St Luke's Guildford

    Guildford

  • Royal Liverpool

    Liverpool

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Clatterbridge Oncology Centre

    Metropolitan Borough of Wirral

  • Newcastle

    Newcastle

  • Royal Marsden NHS Foundation Trust

    Sutton

Other trials in United Kingdom

About this study

Official title: 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.

Read the detailed description

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

Being tested
epirubicin, oxaliplatin, capecitabine (EOX), EOX + panitumumab
Keywords
epirubicin, oxaliplatin, capecitabine, panitumumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epirubicin, oxaliplatin, capecitabine (EOX)Drug

    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

  • EOX + panitumumabDrug

    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

Study groups in NCT00824785
Study groupRoleWhat they receive
Arm A EOXActive comparatorEOX chemotherapy (epirubicin, oxaliplatin and capecitabine)
Receives: Drug: epirubicin, oxaliplatin, capecitabine (EOX)
Arm B EOX + panitumumab.Active comparatorEOX chemotherapy with the addition of panitumumab 9mg/kg every 21 days
Receives: Drug: EOX + panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Study closed early due to lack of efficacy

    Measured: Early termination

Secondary outcomes (1)

  1. response rate, toxicity, quality of life and PFS

    Study closed early due to lack of efficacy

    Measured: Early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2013 (estimated)
  4. Study completionFeb 2013 (estimated)

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00824785
Sponsor's protocol ID
CCR3024
Acronym
REAL3
Status last verified
Dec 2012
First submitted
16 Jan 2009
Last updated
11 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33199443

  • 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.

    PubMed 23594787

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epirubicin, oxaliplatin, capecitabine (EOX) and EOX + panitumumab in people with Oesophago-gastric Cancer, run by Royal Marsden NHS Foundation Trust at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Early termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00824785, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.

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