Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000108617
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised phase II study of preoperative chemotherapy versus preoperative chemoradiation therapy for resectable carcinoma of the oesophagus and gastro-oesophageal junction
Scientific title
A randomised phase II study of feasability, toxicity and quality of life for patients undergoing preoperative chemotherapy versus preoperative chemoradiation therapy for resectable carcinoma of the oesophagus and gastro-oesophageal junction
Secondary ID [1] 106 0
Surgical oesophageal trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma of the oesophagus 192 0
Gastro-oesophageal junction 193 0
Condition category
Condition code
Cancer 215 215 0 0
Oesophageal (gullet)
Cancer 216 216 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery, preoperative chemotherapy, preoperative chemoradiation therapy.
Intervention code [1] 120 0
Treatment: Surgery
Intervention code [2] 2617 0
Treatment: Drugs
Intervention code [3] 2618 0
Treatment: Other
Comparator / control treatment
Phase II study comparing 2 treatments, neither an accepted control treatment
Control group
Active

Outcomes
Primary outcome [1] 260 0
Feasibility
Timepoint [1] 260 0
At analysis, 13 months after the last patient is enrolled
Primary outcome [2] 261 0
Toxicity
Timepoint [2] 261 0
Weeks 1, 4, 6, pre-surgery, post surgery 3 monthly for the first 2 years, 4 monthly in the third year, 6 monthly until 12 months after the last patient is enrolled
Primary outcome [3] 262 0
Quality of life
Timepoint [3] 262 0
Baseline, pre-surgery and 6 monthly until 12 months after the last patient is enrolled
Secondary outcome [1] 584 0
Progression free survival
Timepoint [1] 584 0
Until 12 months after the last patient is enrolled, ie until June 2008
Secondary outcome [2] 585 0
Overall survival
Timepoint [2] 585 0
Until 12 months after the last patient is enrolled, ie until June 2008

Eligibility
Key inclusion criteria
Histologically proven squamus cell carcinoma or adenocarcinoma of the oesophagus or gastro-oesophageal junction, resectable disease, no evidence of extrathoracic or extragastric spread apart from resectable perigastric or mediastinal nodes, adequate haematological & renal function, no previous radiation to the chest, no evidence of tracheo or broncho oesophageal fistula, written informed consent.
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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers generated with Statview software n=100, no restrictions used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 276 0
Self funded/Unfunded
Name [1] 276 0
Country [1] 276 0
Primary sponsor type
Individual
Name
Associate Professor Bryan Burmeister
Address
Cancer Services Executive, Wing C, Level 2, Building 1, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba 4102
Country
Australia
Secondary sponsor category [1] 210 0
Individual
Name [1] 210 0
Associate Professor Mark Smithers
Address [1] 210 0
GIAST Clinic, Mater Medical Centre, 293 Vulture Stm South Brisbane 4101
Country [1] 210 0
Australia
Secondary sponsor category [2] 211 0
Individual
Name [2] 211 0
Dr Euan Walpole
Address [2] 211 0
Cancer Services Executive, Wing C, Level 2, Building 1, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba 4102
Country [2] 211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1124 0
Princess Alexandra Hospital
Ethics committee address [1] 1124 0
Ethics committee country [1] 1124 0
Australia
Date submitted for ethics approval [1] 1124 0
Approval date [1] 1124 0
Ethics approval number [1] 1124 0
Ethics committee name [2] 1125 0
Mater Private Hospital
Ethics committee address [2] 1125 0
Ethics committee country [2] 1125 0
Australia
Date submitted for ethics approval [2] 1125 0
Approval date [2] 1125 0
Ethics approval number [2] 1125 0

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

Contacts
Principal investigator
Name 36113 0
Address 36113 0
Country 36113 0
Phone 36113 0
Fax 36113 0
Email 36113 0
Contact person for public queries
Name 9309 0
Associate Professor Bryan Burmeister
Address 9309 0
Radiation Oncology
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Brisbane QLD 4102
Country 9309 0
Australia
Phone 9309 0
+61 7 32406581
Fax 9309 0
+61 7 32402252
Email 9309 0
bryan_burmeister@health.qld.gov.au
Contact person for scientific queries
Name 237 0
Janine Thomas
Address 237 0
GIAST Clinic, Mater Medical Centre, 293 Vulture Stm South Brisbane 4101
Country 237 0
Australia
Phone 237 0
07 3844 8500
Fax 237 0
07 3844 8511
Email 237 0
janine1972@hotmail.com

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.