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
ACTRN12608000061336
Ethics application status
Approved
Date submitted
28/01/2008
Date registered
31/01/2008
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
ANTS Trial (Australian Neoadjuvant Therapy Study for Non-small Cell Lung Cancer)
Scientific 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.
Secondary ID [1] 515 0
Trial Number: ALTG 04/008
Universal Trial Number (UTN)
Trial acronym
ANTS (Australian Neoadjuvant Therapy Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 2776 0
Condition category
Condition code
Cancer 2913 2913 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 2515 0
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
Control group
Active

Outcomes
Primary outcome [1] 3788 0
To estimate the pathologic response rate of chemotherapy plus cetuximab and relate this rate to that for chemotherapy alone.
Timepoint [1] 3788 0
Following 3 cycles of chemotherapy (approximately 9 weeks)
Secondary outcome [1] 6392 0
To compare response as assessed by Computed Tomography (CT) scanning
Timepoint [1] 6392 0
Following 3 cycles of chemotherapy (approximately 9 weeks)

Eligibility
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Tumour and normal tissue specimens will be collected to investigate the molecular effects of chemotherapy and of cetuximab
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2008
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)
Recruitment postcode(s) [1] 745 0
3084

Funding & Sponsors
Funding source category [1] 3030 0
Commercial sector/Industry
Name [1] 3030 0
Sanofi-Aventis
Country [1] 3030 0
Australia
Funding source category [2] 3031 0
Commercial sector/Industry
Name [2] 3031 0
Merck Serono
Country [2] 3031 0
Australia
Funding source category [3] 3032 0
Government body
Name [3] 3032 0
National Health & Medical Research Council
Country [3] 3032 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Rd, Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 2736 0
None
Name [1] 2736 0
Address [1] 2736 0
Country [1] 2736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4990 0
Human Research Ethics Committee, Austin Health
Ethics committee address [1] 4990 0
Studley Rd, Heidelberg, VIC 3084
Ethics committee country [1] 4990 0
Australia
Date submitted for ethics approval [1] 4990 0
Approval date [1] 4990 0
01/04/2007
Ethics approval number [1] 4990 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28339 0
Address 28339 0
Country 28339 0
Phone 28339 0
Fax 28339 0
Email 28339 0
Contact person for public queries
Name 11496 0
Bev McClur
Address 11496 0
CBCT, Pater MacCallum Cancer Centre, St Andrews Place, East Melbourne, VIC 3002
Country 11496 0
Australia
Phone 11496 0
+61 3 9656 1266
Fax 11496 0
+61 3 9656 1420
Email 11496 0
[email protected]
Contact person for scientific queries
Name 2424 0
A/Prof Paul Mitchell
Address 2424 0
Austin Health, Studley Rd, Heidelberg, VIC 3084
Country 2424 0
Australia
Phone 2424 0
+61 3 9496 3546
Fax 2424 0
+61 3 9496 3379
Email 2424 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.