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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
ECF Gastric Study
Scientific title
A Phase II Feasibility Study Of Pre-Operative And Post-Operative Chemotherapy Using Epirubicin, Cisplatin And Protracted Venous Infusion Fluorouracil (ECF) In Patients With Advanced But Operable Gastric Cancer
Secondary ID [1] 211 0
Australasian Gastro-Intestinal Trials Group: AG9601
Secondary ID [2] 212 0
National Clinical Trials Registry: NCTR178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 850 0
Condition category
Condition code
Cancer 917 917 0 0

Study type
Description of intervention(s) / exposure
Chemotherapy: Epirubicin, 5FU, Cisplatin; for 18 weeks total (9 pre-surgery, 9 post-surgery)
Intervention code [1] 565 0
Comparator / control treatment
Control group

Primary outcome [1] 1194 0
chemotherapy morbidity
Timepoint [1] 1194 0
Measured at the end of every cycle
Primary outcome [2] 1195 0
chemotherapy mortality
Timepoint [2] 1195 0
Measured at the end of every cycle
Primary outcome [3] 1196 0
surgical morbidity
Timepoint [3] 1196 0
Measured post surgery
Primary outcome [4] 1197 0
surgical mortality
Timepoint [4] 1197 0
Measured post surgery
Primary outcome [5] 1198 0
complete response rates
Timepoint [5] 1198 0
Measured 6-weekly by scans
Secondary outcome [1] 2190 0
Timepoint [1] 2190 0

Key inclusion criteria
Histologically verified newly diagnosed locally advanced but operable adenocarcinoma or undifferentiated carcinoma of the stomach (including cardio-esophageal tumours where at least 50% of the tumour involves the stomach).Patient performance status WHO 0-1 (see Appendix 2)Bi-dimensionally measurable or evaluable disease as assessed by upper GI endoscopy, with or without endolumenal ultrasoundPeripheral blood white cell count greater than 3.5x109/l and platelet count greater than 100x109/lA glomerular filtration rate of greater than or equal to 60mls/minute. This can be measured using an EDTA clearance or 24 hour urinary creatinine clearance at the investigators discretionSerum bilirubin of less than or equal to 20mmol/LPatients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervixPatients (male and female) with fertility potential should undertake adequate contraceptionWritten informed consent must be obtained from the patientNo medical or psychiatric condition that impairs the patients ability to give informed consentNo prior chemotherapy or radiation therapyNo uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with an abnormal ECG or cardiac history having a LVEF of <50% No clinically significant hearing loss.No other serious uncontrolled medical conditions impairing the safety of chemotherapy or surgeryNo pregnant or breast-feeding woman; any woman of childbearing potential must have a pregnancy test prior to treatment No clinical evidence of distant spread, as indicated by hard supraclavicular lymph node enlargment, irregular hepatomegaly, ascites or a rectal shelf indicating transcoelomic spread to the rectovesical or rectovaginal pouch. No evidence of distant spread on Chest X-ray or CT scan of the chest, abdomen, and pelvis.No evidence of "Early gastric cancer" (Stage Ia) - Endoscopic and histological appearence consistent with a carcinoma which is confined to the mucosa or submucosa.No evidence of esophagogastric or antropyloric obstruction to a degree which prevents ingestion of fluids. (It may be regarded as reasonable to support such a patient with parenteral nutrition through one treatment cycle in the hope that an early response may improve the patient's ability to eat).No prior surgery for the tumour eg bypass, attempted resection or staging (except for laparoscopy)No aspect of the patient which leads the responsible surgeon to believe that the patient represents an especially high operative risk because of build, previous surgery, poor nutritional status or other factors.
Minimum age
Not stated
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1012 0
Commercial sector/Industry
Name [1] 1012 0
Address [1] 1012 0
Country [1] 1012 0
Primary sponsor type
Other Collaborative groups
AGITG sponsored trial conducted through NHMRC CTC
Secondary sponsor category [1] 873 0
Other Collaborative groups
Name [1] 873 0
Address [1] 873 0
Country [1] 873 0
Secondary sponsor category [2] 874 0
Name [2] 874 0
NHMRC Clinical Trials Centre
Address [2] 874 0
Country [2] 874 0

Ethics approval
Ethics application status

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 36265 0
Address 36265 0
Country 36265 0
Phone 36265 0
Fax 36265 0
Email 36265 0
Contact person for public queries
Name 9754 0
Burcu Cakir
Address 9754 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9754 0
Phone 9754 0
+61 2 95625334
Fax 9754 0
+61 2 95625094
Email 9754 0
Contact person for scientific queries
Name 682 0
Michael Findlay
Address 682 0
Locked Bag 77
Camperdown NSW 1450
Country 682 0
Phone 682 0
+61 2 95625334
Fax 682 0
Email 682 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary