Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000700639
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
Oesophageal Trial
Scientific title
A Randomised Phase III Clinical Trial
Comparing Surgery Alone with Concurrent Preoperative Chemotherapy and Radiation Followed by Surgery For Localised Resectable Carcinoma of the Oesophagus
Secondary ID [1] 209 0
Australasian Gastro-Intestinal Trials Group: IG9401
Secondary ID [2] 210 0
National Clinical Trials Registry: NCTR117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal carcinoma 849 0
Condition category
Condition code
Cancer 916 916 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 months of preoperative chemotherapy and radiotherapy followed by surgery vs surgery alone
Intervention code [1] 545 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1192 0
Progression free survival
Timepoint [1] 1192 0
Primary outcome [2] 1193 0
Overall survival
Timepoint [2] 1193 0
Secondary outcome [1] 2189 0
Toxicity
Timepoint [1] 2189 0

Eligibility
Key inclusion criteria
Histologically proven invasive squamous cell carcinoma or adenocarcinoma of the oesophagus.Technically resectable disease, as assessed in consultation with intended surgeon, with no planned post-operative anti-tumour treatment.No evidence of extrathoracic spread. (Tumour in supraclavicular and/or coeliac nodes renders patient ineligible.)Tumour is NOT located in cervical oesophagus requiring pharyngo-oesophagectomy.Tumour is NOT predominantly below the oesophagogastric junction and involving the stomach. (i.e. Most of the macroscopically visible tumour must be above the O-G junction and technically within the oesophagus.)Medically fit for surgical resection, defined as having adequate cardiopulmonary function and ECOG performance status of 0 or 1.Adequate haematological function, defined as having WBC > 4 x 109/litre and platelets > 100 x 109/litre.Adequate renal function, defined as creatinine clearance > 60 ml/min calculated (using Cockcroft & Gault formula - see Appendix 6). If calculated creatinine clearance is < 60ml/min, glomerular filtration rate can be measured by an alternative method. If results from this are creatinine clearance > 60mls/min the patient is eligible.No previous radiotherapy to the chest, no previous chemotherapy.No previous malignancy, with the exception of non-metastatic SCC of skin, other non-melanoma skin cancer, carcinoma in situ of the cervix. Cases for Special Eligibility with regard to this criteria may be presented to the study chair for discussion.No evidence of tracheo- or broncho-oesophageal fistula.Not pregnant or lactating.Written informed consent of the patient according to local ethics committee guidelines.
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
centralised randomisation database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/1994
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1011 0
Other
Name [1] 1011 0
Grants
Country [1] 1011 0
Primary sponsor type
Government body
Name
AGITG/NHMRC Clinical Trials Centre
Address
Country
Australia
Secondary sponsor category [1] 872 0
Other Collaborative groups
Name [1] 872 0
AGITG
Address [1] 872 0
Country [1] 872 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35857 0
Address 35857 0
Country 35857 0
Phone 35857 0
Fax 35857 0
Email 35857 0
Contact person for public queries
Name 9734 0
Burcu Cakir
Address 9734 0
Locked Bag 77
Camperdown NSW 1450
Country 9734 0
Australia
Phone 9734 0
+61 2 95625334
Fax 9734 0
+61 2 95625094
Email 9734 0
[email protected]
Contact person for scientific queries
Name 662 0
Bryan Burmeister
Address 662 0
Queensland Radium Institute
Mater Centre
South Brisbane QLD 4101
Country 662 0
Australia
Phone 662 0
+61 7 38403255
Fax 662 0
+61 7 38403399
Email 662 0
[email protected]

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.