Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000701628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
1/11/2005
Date last updated
28/02/2012
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
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chemotherapy: Epirubicin, 5FU, Cisplatin; for 18 weeks total (9 pre-surgery, 9 post-surgery)
Intervention code [1] 565 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
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
Nil
Timepoint [1] 2190 0

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
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
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/12/1996
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 9754 0
+61 2 95625334
Fax 9754 0
+61 2 95625094
Email 9754 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 682 0
Michael Findlay
Address 682 0
Locked Bag 77
Camperdown NSW 1450
Country 682 0
Australia
Phone 682 0
+61 2 95625334
Fax 682 0
Email 682 0
mp.findlay@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.