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Trial registered on ANZCTR


Registration number
ACTRN12606000163505
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
9/05/2006
Date last updated
16/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
ATTAX
Scientific title
ATTAX: A randomised phase II study evaluating tumour response rates of a weekly schedule of docetaxel with cisplatin and 5-FU (wTCF) or with Capecitabine (wTX) in advanced oesophago-gastric cancer.
Secondary ID [1] 258 0
Australasian Gastro-Intestinal Trials Group: AG0603G
Universal Trial Number (UTN)
Trial acronym
ATTAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally recurrent or metastatic oesophago-gastric cancer 1136 0
Condition category
Condition code
Cancer 1215 1215 0 0
Oesophageal (gullet)
Cancer 1216 1216 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has two treatment arms:
Weekly TCF consisting of Docetaxel 30 mg/m2 d1, d8; Cisplatin 60 mg/m2 d1 and protracted venous infusion fluorouracil (5-FU) 200 mg/m2/d for 21d
Weekly TX consisting of Docetaxel 30 mg/m2 d1, d8; Capecitabine 800 mg/m2 bd orally d1-14.
Each cycle administered 3 weekly for a total of 8 cycles.
Intervention code [1] 562 0
Treatment: Drugs
Comparator / control treatment
This study has two treatment arms, which are not compared, therefore there is no comparator/control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1647 0
To evaluate tumour response rates of weekly docetaxel, cisplatin and 5-FU or weekly docetaxel and capecitabine in the treatment of patients with metastatic or locally recurrent oesophago-gastric cancer. Treatment will continue for 24 weeks and tumour response will be assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Timepoint [1] 1647 0
Assessed every 6 weeks.
Secondary outcome [1] 2946 0
To assess comparative overall survival, progression-free survival, treatment related toxicity, disease associated symptoms and quality of life using treatment with weekly docetaxel, cisplatin and 5-FU or weekly docetaxel and capecitabine.
Timepoint [1] 2946 0
Overall survival will be measured from date of patient entry onto the study to date of death from any cause. At completion of protocol treatment patients will be followed up every 12 weeks until disease progression.

Eligibility
Key inclusion criteria
Histological diagnosis of metastatic or locally recurrent oesophago-gastric cancer (squamous cell, adenocarcinoma or undifferentiated carcinoma)-Any primary oesophago-gastric site (oesophagus, oesophago-gastric junction (OGJ) or stomach)-Unidimensional measurable disease as assessed by CT scan (RECIST criteria)- No prior radiation except for; Adjuvant radiation (radiation alone or chemo-radiation allowed) which must have been completed >12 months ago. For patients who have received adjuvant radiotherapy, the site(s) of measurable disease should include at least one which was not encompassed by the radiation field(s) unless this site has demonstrated clear progression.Palliative radiotherapy provided there was no concurrent chemotherapy administered, all radiation toxicities have resolved to grade 1 or less and at least 14d has elapsed from the last dose of radiotherapy until the start of chemotherapy in ATTAX. For patients who have received palliative radiotherapy, the site(s) of measurable disease should include at least one which was not encompassed by the radiation field(s)-No prior chemotherapy agents, except adjuvant chemotherapy > 12 months ago.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic disease of the central nervous system.

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)
Central randomisation by fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified urn model with stratification by Site and Eastern Conference Oncology Group (ECOG) status. Randomisation lists were generated by computer and the randomisation process was done manually.
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/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 1327 0
Commercial sector/Industry
Name [1] 1327 0
Educational Grant from Sanofi-Aventis
Address [1] 1327 0
12-24 Talavera Road, Macquarie Park NSW 2113
Country [1] 1327 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group A(AGITG)
Address
92-94 Parramatta Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 251526 0
University
Name [1] 251526 0
NHMRC Clinical Trials Centre, University of Sydney
Address [1] 251526 0
92-94 Parramatta Road, Camperdown, NSW, 2050
Country [1] 251526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2653 0
Royal North Shore Hospital
Ethics committee address [1] 2653 0
Ethics committee country [1] 2653 0
Australia
Date submitted for ethics approval [1] 2653 0
Approval date [1] 2653 0
24/05/2005
Ethics approval number [1] 2653 0
AG0603G
Ethics committee name [2] 2654 0
Westmead
Ethics committee address [2] 2654 0
Ethics committee country [2] 2654 0
Australia
Date submitted for ethics approval [2] 2654 0
Approval date [2] 2654 0
15/03/2005
Ethics approval number [2] 2654 0
Ethics committee name [3] 2655 0
Nepean Cancer Care Centre
Ethics committee address [3] 2655 0
Ethics committee country [3] 2655 0
Australia
Date submitted for ethics approval [3] 2655 0
Approval date [3] 2655 0
22/11/2004
Ethics approval number [3] 2655 0
Ethics committee name [4] 2656 0
Prince of Wales Hospital
Ethics committee address [4] 2656 0
Ethics committee country [4] 2656 0
Australia
Date submitted for ethics approval [4] 2656 0
Approval date [4] 2656 0
02/12/2004
Ethics approval number [4] 2656 0
Ethics committee name [5] 2657 0
Saint Vincent's Hospital Darlinghurst
Ethics committee address [5] 2657 0
Ethics committee country [5] 2657 0
Australia
Date submitted for ethics approval [5] 2657 0
Approval date [5] 2657 0
14/10/2004
Ethics approval number [5] 2657 0
Ethics committee name [6] 2658 0
Condord
Ethics committee address [6] 2658 0
Ethics committee country [6] 2658 0
Australia
Date submitted for ethics approval [6] 2658 0
Approval date [6] 2658 0
18/07/2005
Ethics approval number [6] 2658 0
Ethics committee name [7] 2659 0
Campelltown-Liverpool Hospital
Ethics committee address [7] 2659 0
Ethics committee country [7] 2659 0
Australia
Date submitted for ethics approval [7] 2659 0
Approval date [7] 2659 0
27/09/2004
Ethics approval number [7] 2659 0
Ethics committee name [8] 2660 0
Bankstown-Lidcombe Hospital
Ethics committee address [8] 2660 0
Ethics committee country [8] 2660 0
Australia
Date submitted for ethics approval [8] 2660 0
Approval date [8] 2660 0
26/07/2004
Ethics approval number [8] 2660 0
Ethics committee name [9] 2661 0
Newcastle Mater Misericordia Hospital
Ethics committee address [9] 2661 0
Ethics committee country [9] 2661 0
Australia
Date submitted for ethics approval [9] 2661 0
Approval date [9] 2661 0
22/09/2004
Ethics approval number [9] 2661 0
Ethics committee name [10] 2662 0
Peter MacCallum Cancer Centre
Ethics committee address [10] 2662 0
Ethics committee country [10] 2662 0
Australia
Date submitted for ethics approval [10] 2662 0
Approval date [10] 2662 0
07/09/2004
Ethics approval number [10] 2662 0
Ethics committee name [11] 2663 0
Saint Vincent's Hospital Melbourne
Ethics committee address [11] 2663 0
Ethics committee country [11] 2663 0
Australia
Date submitted for ethics approval [11] 2663 0
Approval date [11] 2663 0
15/10/2004
Ethics approval number [11] 2663 0
Ethics committee name [12] 2664 0
Frankston Hospital
Ethics committee address [12] 2664 0
Ethics committee country [12] 2664 0
Australia
Date submitted for ethics approval [12] 2664 0
Approval date [12] 2664 0
19/10/2004
Ethics approval number [12] 2664 0
Ethics committee name [13] 2665 0
Austin Health
Ethics committee address [13] 2665 0
Ethics committee country [13] 2665 0
Australia
Date submitted for ethics approval [13] 2665 0
Approval date [13] 2665 0
18/05/2004
Ethics approval number [13] 2665 0
Ethics committee name [14] 2666 0
Monash Medical Centre
Ethics committee address [14] 2666 0
Ethics committee country [14] 2666 0
Australia
Date submitted for ethics approval [14] 2666 0
Approval date [14] 2666 0
20/12/2004
Ethics approval number [14] 2666 0
Ethics committee name [15] 2667 0
Border Medical Oncology
Ethics committee address [15] 2667 0
Ethics committee country [15] 2667 0
Australia
Date submitted for ethics approval [15] 2667 0
Approval date [15] 2667 0
16/06/2004
Ethics approval number [15] 2667 0
Ethics committee name [16] 2668 0
Princess Alexandra Hospital
Ethics committee address [16] 2668 0
Ethics committee country [16] 2668 0
Australia
Date submitted for ethics approval [16] 2668 0
Approval date [16] 2668 0
06/07/2004
Ethics approval number [16] 2668 0
Ethics committee name [17] 2669 0
Queen Elizabeth Hospital
Ethics committee address [17] 2669 0
Ethics committee country [17] 2669 0
Australia
Date submitted for ethics approval [17] 2669 0
Approval date [17] 2669 0
17/05/2005
Ethics approval number [17] 2669 0
Ethics committee name [18] 2670 0
Sir Charles Gairdner Hospital
Ethics committee address [18] 2670 0
Ethics committee country [18] 2670 0
Australia
Date submitted for ethics approval [18] 2670 0
Approval date [18] 2670 0
23/06/2004
Ethics approval number [18] 2670 0
Ethics committee name [19] 2671 0
Royal Perth Hospital
Ethics committee address [19] 2671 0
Ethics committee country [19] 2671 0
Australia
Date submitted for ethics approval [19] 2671 0
Approval date [19] 2671 0
03/08/2004
Ethics approval number [19] 2671 0
Ethics committee name [20] 2672 0
Fremantle Hospital
Ethics committee address [20] 2672 0
Ethics committee country [20] 2672 0
Australia
Date submitted for ethics approval [20] 2672 0
Approval date [20] 2672 0
27/09/2004
Ethics approval number [20] 2672 0
Ethics committee name [21] 2673 0
Royal Hobart
Ethics committee address [21] 2673 0
Ethics committee country [21] 2673 0
Australia
Date submitted for ethics approval [21] 2673 0
Approval date [21] 2673 0
16/03/2005
Ethics approval number [21] 2673 0
Ethics committee name [22] 2674 0
Christchurch
Ethics committee address [22] 2674 0
Ethics committee country [22] 2674 0
New Zealand
Date submitted for ethics approval [22] 2674 0
Approval date [22] 2674 0
22/06/2004
Ethics approval number [22] 2674 0

Summary
Brief summary
Most cases of oesophageal and gastric cancer are locally advanced or metastatic at presentation. Chemotherapy prolongs survival and improves quality of life in such patients, but standard chemotherapy for this disease has not been defined.
Doxetaxel is a taxane with promising single agent activity in oesophago-gastric cancer. Combination chemotherapy regimens based on docetaxel may therefore have significant activity with a more favourable toxicity profile.
This randomised phase II study explores the activity and toxicity of two novel docetaxel based regimens; weekly docetaxel, cisplatin and infused 5-FU (wTCF) and weekly docetaxel plus capecitabine (wTX) in patients with metastatic oesophago-gastric cancer. Based on the results achieved in this study, the AGITG would aim to test the best regimen in a future phase III study comparing it with ECF or another accepted standard regimen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35847 0
Address 35847 0
Country 35847 0
Phone 35847 0
Fax 35847 0
Email 35847 0
Contact person for public queries
Name 9751 0
Ms Burcu Cakir
Address 9751 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9751 0
Australia
Phone 9751 0
+61 2 95625000
Fax 9751 0
+61 2 95625094
Email 9751 0
Burcu.Cakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 679 0
Dr Niall Tebbutt
Address 679 0
Department of Medical Oncology
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 679 0
Australia
Phone 679 0
+61 3 94963217
Fax 679 0
+61 3 94576698
Email 679 0
niall.tebbutt@ludwig.edu.au

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