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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082570
ACTR Number:
ACTRN12608000061336
Trial Status:
Registered
Date Submitted:
28/01/2008
Date Registered:
31/01/2008
Page 1
Public title:
ANTS Trial (Australian Neoadjuvant Therapy Study for Non-small Cell Lung Cancer)
Update:
Reason:
ANZCTR registration title:
A randomised phase II study comparing cisplatin and docetaxel with or without cetuximab given as neoadjuvant therapy in patients with stage II and IIIA resectable non-small cell lung cancer.
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Reason:
Secondary ID:
Trial Number: ALTG 04/008
UTN:
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Reason:
Trial acronym:
ANTS (Australian Neoadjuvant Therapy Study)
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Page 2
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC)
Condition category:
Condition code:
Cancer
Lung - Non small cell
Page 3
Description of intervention(s) / exposure:
Standard chemotherapy (cisplatin 75mg/m2 i.v. and docetaxel 75mg/m2 i.v., 3-weekly for 3 cycles) plus cetuximab 400mg/m2 i.v., then 250mg/m2 i.v. weekly, followed by surgery
Update:
Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
Standard chemotherapy (cisplatin 75mg/m2 i.v. and docetaxel 75mg/m2 i.v., 3-weekly for 3 cycles), followed by surgery
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Reason:
Control group:
Active
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Reason:
Page 4
Primary outcome:
To estimate the pathologic response rate of chemotherapy plus cetuximab and relate this rate to that for chemotherapy alone.
Timepoint:
Following 3 cycles of chemotherapy (approximately 9 weeks)
Secondary outcome:
To compare response as assessed by Computed Tomography (CT) scanning
Timepoint:
Following 3 cycles of chemotherapy (approximately 9 weeks)
Page 5
Key inclusion criteria:
1) Histological diagnosis of NSCLC
2) Adequate baseline histological specimen available
3) Measurable primary tumour
4) Stage II or IIIA
5) Considered to be surgically resectable by thoracic surgeon
6) No prior therapy for NSCLC
7) Performance Status 0-1
8) Peripheral neuropathy no worse than grade I
9) Adequate organ function including lung, hepatic, renal and haematological function
10) Written informed consent
Update:
Reason:
Minimum Age:
18
Years
Update:
Reason:
Maximum Age:
No limit
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Reason:
Gender:
Both males and females
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Reason:
Healthy volunteers?
No
Update:
Reason:
Key exclusion criteria:
1) No prior malignancy within 5 years 2) No other concurrent investigational drug 3) No active infection 4) No pregnancy or breast feeding 5) No serious concomitant medical or psychiatric disorders 6) No significant cardiovascular disease 7) No concurrent systemic corticosteroid (prednisolone >10 mg/day, or equivalent) 8) No history of severe hypersensitivity reactions to polysorbate 80 or any of the study medications.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Treatment
Update:
Allocation to intervention:
Randomised controlled trial
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Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Eligible patients will be registered and randomised via the Coordinating Trial Centre at Peter MacCallum Cancer Centre. Randomisation will be 2:1 experimental vs standard arms.
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Minimisation
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Reason:
Masking / blinding:
Open (masking not used)
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Reason:
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Reason:
Assignment:
Update:
Reason:
Other design features (specify):
Tumour and normal tissue specimens will be collected to investigate the molecular effects of chemotherapy and of cetuximab
Update:
Reason:
Type of endpoint(s):
Efficacy
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Reason:
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Page 7
Phase
Phase 2
Update:
Reason:
Anticipated or actual date of first participant enrolement:
1/02/2008
Update:
Reason:
Target sample size:
100
Update:
Reason:
Recruitment status:
Not yet recruiting
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Reason:
Page 8
Funding source 1:
Commercial sector/Industry
Name:
Sanofi-Aventis
Address:
12-24 Talavera Rd Macquarie Park NSW 2113
Country:
Australia
Funding source 2:
Commercial sector/Industry
Name:
Merck Serono
Address:
U3 / 25 Frenchs Forest Frenchs Forest NSW 2086
Country:
Australia
Funding source 3:
Government funding body e.g. Australian Research Council
Name:
National Health & Medical Research Council
Address:
GPO Box 1421 Canberra ACT 2601
Country:
Australia
Primary sponsor:
Hospital
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Reason:
Name:
Austin Health
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Reason:
Address:
Studley Rd, Heidelberg, VIC 3084
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Reason:
Country:
Australia
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Reason:
Secondary sponsor:
None
Name:
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Human Research Ethics Committee, Austin Health
Address:
Studley Rd, Heidelberg, VIC 3084
Country:
Australia
Date of approval:
1/04/2007
HREC Number:
Countries of recruitment:
Australia
Postcode:
3084
Brief summary:
The primary objective of the study is to estimate the benefit of adding cetuximab to standard chemotherapy, administered prior to surgery. Cetuximab inhibits the Epidermal Growth Factor receptor. Additional objectives are to examine the relationships between various measures of tumour shrinkage and various molecular analyses of normal and cancer tissues. This may provide information on how cetuximab works, and which patients benefit most from the drug, as well as further information on the effects of chemotherapy.
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Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Bev McClur
Update:
Reason:
Address:
CBCT, Pater MacCallum Cancer Centre, St Andrews Place, East Melbourne, VIC 3002
Update:
Reason:
Country:
Australia
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Reason:
Tel:
+61 3 9656 1266
Update:
Reason:
Fax:
+61 3 9656 1420
Update:
Reason:
Email:
Bev.McClur@petermac.org
Update:
Reason:
Contact person for scientific queries
Name:
A/Prof Paul Mitchell
Update:
Reason:
Address:
Austin Health, Studley Rd, Heidelberg, VIC 3084
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 3 9496 3546
Update:
Reason:
Fax:
+61 3 9496 3379
Update:
Reason:
Email:
paul.mitchell@austin.org.au
Update:
Reason:
Contact person responsible for updating information
Name:
A/Prof Paul Mitchell
Update:
Reason:
Address:
Austin Health, Studley Rd, Heidelberg, VIC 3084
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 3 9496 3546
Update:
Reason:
Fax:
+61 3 9496 3379
Update:
Reason:
Email:
paul.mitchell@austin.org.au
Update:
Reason:
