Gastro Oesophageal CancerPhase 2ELECTNCT01710592

A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

A Phase 2 study testing Epirubicin, Oxaliplatin and Capecitabine in people with Gastro Oesophageal Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastro Oesophageal Cancer
What is being tested?: Epirubicin, Oxaliplatin and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 6 sitesIreland
Study dates: May 2007to Dec 2012
Phase: Phase 2
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

Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if >12 months previously).
Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (>3 admissions for infective exacerbation in past 12 months) etc.
ECOG performance status ≤ 2.
Age ≥ to 18.
Life expectancy ≥ 3 months

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Adequate renal, hepatic and bone marrow function
Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).
Liver function tests:
Bilirubin ≤ 1.0 x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN,Haemoglobin > 10.0 g/dl, Absolute neutrophil count >1.5 x 109 /L, Platelet count > 100 x109/L.
•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

Symptoms or signs of peripheral neuropathy.
Patients known to have second or third degree heart block.
Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
Pregnant or nursing.
Female of child-bearing potential, or male partner of female of child bearing potential not taking adequate contraceptive precautions.
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Ireland6 sites

Mercy University Hospital
Cork
Beaumont Hospital
Dublin
Mater Misericordiae University hospital & Mater Private Hospital
Dublin
St James's Hospital
Dublin
The Adelaide and Meath Hospital
Dublin
Waterford Regional Hospital
Waterford

Other trials in Ireland

About this study

Official title: A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced gastro-oesophageal cancer, their role, however, in the management of this disease remains unclear. Furthermore it is unclear whether this disease is optimally treated with a combination of two or three cytotoxic drugs. This trial aims to determine whether the combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the comparator arm for this evaluation.

Primary Objective:

Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer.

Secondary Objective:

To examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.

Read the detailed description

This is a randomised two-arm parallel group phase II study. 140 patients will be recruited over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and Oxaliplatin (EITax).

Conditions: Gastro Oesophageal Cancer
Being tested: Epirubicin, Oxaliplatin, Capecitabine, Docetaxel

What participants receive

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

Study groups in NCT01710592
Study group	Role	What they receive
Epirubicin, Oxaliplatin, Capecitabine	Active comparator	* Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle Receives: Drug: Epirubicin; Drug: Oxaliplatin; Drug: Capecitabine
Docetaxel, Oxaliplatin	Active comparator	* Docetaxel 20mg/m2 (days 1, 8 \& 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel) * Oxaliplatin 85mg/m2 (days 1 \& 15)in 250mls of 5% dextrose. i.v. over 2 hours * 6 x 4-weekly cycle Receives: Drug: Oxaliplatin; Drug: Docetaxel

What is being measured

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

Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
Measured: Two Years

Secondary outcomes (4)

In addition we will examine the effect of treatment on time to progression.
Measured: Two Years
To examine the associated toxicity from treatment
Measured: 2 years
To examine the effect of treatment on survival
Measured: 2 years
To examine the effect of treatment on Quality of life.
Measured: 2 years

Timeline

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

May 2007Dec 2012

First posted19 Oct 2012 (estimated)
Study startMay 2007
Primary completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastro Oesophageal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710592
Sponsor's protocol ID: ICORG 06-05
Acronym: ELECT
Status last verified: Jan 2013
First submitted: 15 Oct 2012
Last updated: 10 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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RecruitingPhase 1/2
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Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Gastro Oesophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
ClinicalTrials.gov ID: NCT01710592
Acronym / sponsor ID: ELECT / ICORG 06-05
Conditions: Gastro Oesophageal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Cancer Trials IrelandResearch network
Study start: May 2007
Primary completion: Dec 2012 (actual)
First posted: 19 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

Secondary Objective:

To examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Epirubicin, Oxaliplatin, Capecitabine	Active comparator	Drug: Epirubicin, Drug: Oxaliplatin, Drug: Capecitabine* Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle
Docetaxel, Oxaliplatin	Active comparator	Drug: Oxaliplatin, Drug: Docetaxel* Docetaxel 20mg/m2 (days 1, 8 \& 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel) * Oxaliplatin 85mg/m2 (days 1 \& 15)in 250mls of 5% dextrose. i.v. over 2 hours * 6 x 4-weekly cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if >12 months previously).
Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (>3 admissions for infective exacerbation in past 12 months) etc.
ECOG performance status ≤ 2.
Age ≥ to 18.

Key exclusion criteria (7 listed)

Symptoms or signs of peripheral neuropathy.
Patients known to have second or third degree heart block.
Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
Pregnant or nursing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epirubicin	Drug	Epirubicin, Oxaliplatin, Capecitabine
Oxaliplatin	Drug	Docetaxel, Oxaliplatin, Epirubicin, Oxaliplatin, Capecitabine
Capecitabine	Drug	Epirubicin, Oxaliplatin, Capecitabine
Docetaxel	Drug	Docetaxel, Oxaliplatin

Primary outcome

Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
Time frame: Two Years

4 secondary outcomes

In addition we will examine the effect of treatment on time to progression.
Time frame: Two Years
To examine the associated toxicity from treatment
Time frame: 2 years
To examine the effect of treatment on survival
Time frame: 2 years
To examine the effect of treatment on Quality of life.
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.

Related trials for Gastro Oesophageal Cancer

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Eatock, Dr principal investigator

Cancer Trials Ireland

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epirubicin, Oxaliplatin and Capecitabine in people with Gastro Oesophageal Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.

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 11 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Ireland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710592.

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 10 Jan 2013.