PALLIATIVE CHEMOTHERAPY (EOX) & FISH OIL INFUSION (OMEGAVEN) IN OESOPHAGO-GASTRIC CANCER PATIENTS
- Conditions
- nresectable oesophageal and/or gastric cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003950-24-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
• 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 • WHO 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 GFR>50ml/min, serum bilirubin <1.5x ULN; ALT or AST <2.5x ULN; ALP <3x ULN (in the absence of liver metastases). If liver metastases are present, serum transaminases <5x ULN are permitted.) • Adequate bone marrow function documented within 7 days (Haemoglobin =9g/dL, Platelets =100,000 cells/mm3, Neutrophil Count =1500 cells/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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
• 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 (use of a statin permissible) • Patients with known coagulation disorders • Hypersensitivity to fish, egg protein or to any of the active substances or constituents in the lipid emulsion • 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 • 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method