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

December 10, 2012 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

574

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom
        • Bournemouth
      • Guildford, United Kingdom
        • St Luke's Guildford
      • Liverpool, United Kingdom
        • Royal Liverpool
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust
      • Newcastle, United Kingdom
        • Newcastle
      • Sutton, United Kingdom
        • Royal Marsden NHS Foundation Trust
      • Wirral, United Kingdom
        • Clatterbridge Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A EOX
EOX chemotherapy (epirubicin, oxaliplatin and capecitabine)
Drug: epirubicin, oxaliplatin, capecitabine (EOX)
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
Active Comparator: Arm B EOX + panitumumab.
EOX chemotherapy with the addition of panitumumab 9mg/kg every 21 days
Drug: EOX + panitumumab
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Early termination
Study closed early due to lack of efficacy
Early termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate, toxicity, quality of life and PFS
Time Frame: Early termination
Study closed early due to lack of efficacy
Early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Prof Cunningham, David, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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