NCT01870791

Brief Summary

The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately 16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy regimens, the average survival for these patients is around 9 months from diagnosis. Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil supplementation can improve general well-being and quality of life in patients receiving palliative chemotherapy for a number of different cancer types. It has also been suggested that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy. This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the most widely used regimen for patients with advanced oesophago-gastric cancer, will make this drug regimen more effective at killing oesophago-gastric cancer cells, such that disease progression is delayed. Forty-five patients who have been diagnosed with advanced oesophago-gastric cancer will be recruited over a two year period to receive standard chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be compared to a matched historical control group of patients who have received identical chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat patients with advanced oesophago-gastric cancer in a randomised study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

May 28, 2013

Last Update Submit

May 25, 2016

Conditions

Esophageal NeoplasmGastric Neoplasm

Keywords

Esophageal adenocarcinomaGastric adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival

    Progression free survival from enrolment to disease progression

    12 months

Secondary Outcomes (5)

  • Safety profile

    12 months

  • Efficacy

    6 and 12 months

  • Safety profile

    12 months

  • Safety profile

    12 months

  • Safety profile

    12 months

Study Arms (1)

Omegaven

EXPERIMENTAL

Omegaven in combination with EOX chemotherapy

Drug: Omegaven

Interventions

OmegavenDRUG

Weekly omegaven infusion in combination with EOX chemotherapy

Also known as: Omega-3 fish oil
Omegaven

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed gastric or oesophageal carcinoma (irrespective of subtype), deemed incurable as a result of standard staging investigations.
  • Measurable disease according to RECIST v1.1 criteria on CT within 4 weeks of study entry
  • World Health Organization Performance status 0-2
  • Aged \>18 years
  • Able to give informed written consent
  • Life expectancy \>12 weeks
  • Adequate hepatic and renal function documented within 7 days prior to treatment (estimated glomerular filtration rate\>50ml/min, serum bilirubin \< 1.5x upper limit of normal; Alanine transaminase or aspartate transaminase \< 2.5x upper limit of normal; Alkaline phosphatase\< 3x upper limit of normal (in the absence of liver metastases). If liver metastases are present, serum transaminases \< 5x upper limit of normal are permitted.)
  • Adequate bone marrow function documented within 7 days (haemoglobin ≥9g/dL, platelets ≥100,000cells/mm3, neutrophil count ≥1500cells/mm3)
  • Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment
  • Willing to use contraception if applicable
  • Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial

You may not qualify if:

  • Prior radical treatment within 6 months of relapse
  • Prior treatment with any systemic chemotherapy for metastatic disease
  • Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study
  • Patients with locally advanced disease deemed suitable for radical chemo-radiotherapy
  • Known hyperlipidaemic state
  • Hypersensitivity to fish- or egg protein or to any of the active substances or constituents in the lipid emulsion
  • Patients with known coagulation disorders
  • Any general contra-indications to infusion therapy - pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
  • Any unstable medical conditions - uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis
  • Known HIV or hepatitis B or C carrier
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol
  • History of malignancy other than gastric or oesophageal cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  • Major surgical procedure or significant traumatic injury within 4 weeks of treatment
  • Cerebral metastases
  • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Publications (1)

  • Eltweri AM, Thomas AL, Fisk HL, Arshad A, Calder PC, Dennison AR, Bowrey DJ. Plasma and erythrocyte uptake of omega-3 fatty acids from an intravenous fish oil based lipid emulsion in patients with advanced oesophagogastric cancer. Clin Nutr. 2017 Jun;36(3):768-774. doi: 10.1016/j.clnu.2016.06.001. Epub 2016 Jun 7.

    PMID: 27342748DERIVED

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

fish oil triglyceridesFish Oils

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • David J Bowrey, MD

    University Hospitals, Leicester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

June 6, 2013

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

GB(1)