ECF Gastric Study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12605000701628
• Date of registration: 01/11/2005
• Prospective Registration: No
• Primary sponsor: AGITG sponsored trial conducted through NHMRC CTC
• 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
• Date of first enrolment: 17/12/1996
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12605000701628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Burcu Cakir

• Name: Michael Findlay

Key inclusion & exclusion criteria

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.
Exclusion criteria: No exclusion criteria

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Gastric Cancer;
Gastric Cancer

Cancer - Stomach

Intervention(s)

Chemotherapy: Epirubicin, 5FU, Cisplatin; for 18 weeks total (9 pre-surgery, 9 post-surgery)

Primary Outcome(s)

chemotherapy mortality[Measured at the end of every cycle]

surgical mortality [Measured post surgery]

complete response rates[Measured 6-weekly by scans]

chemotherapy morbidity[Measured at the end of every cycle]

surgical morbidity[Measured post surgery]

Secondary ID(s)

Australasian Gastro-Intestinal Trials Group: AG9601

National Clinical Trials Registry: NCTR178

Source(s) of Monetary Support

Pharmacia

Secondary Sponsor(s)

NHMRC Clinical Trials Centre