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Trial registered on ANZCTR


Registration number
ACTRN12611000728932
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
12/07/2011
Date last updated
12/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised trial of predictive assay-directed chemotherapy in non-small cell lung cancer (NSCLC) and mesothelioma
Scientific title
A Randomised trial of predictive assay-directed chemotherapy in non-small cell lung cancer (NSCLC) and mesothelioma
Secondary ID [1] 262612 0
none
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non small cell lung cancer 257249 0
Mesothelioma 257250 0
Lung Cancer 268299 0
Condition category
Condition code
Cancer 257389 257389 0 0
Lung - Non small cell
Cancer 257390 257390 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial particaipants in the testing arm of the trial will recieve chemotherapy based on the results of chemosensitivity testing of tumour biopsy samples. The drugs used will be chemotherapy drugs currently already approved for the treatment of lung cancer.
Participants may recieve one of or a combination of the following drugs:Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane).
Standard drug doses will be administered by intravenous infusion for up to 6 cycles of chemotherapy with each cyle lasting 3 weeks or until disease progression.
Exact dose amounts will be determined by the treating oncologists.

Particaipants in the control arm of the trails will recieve the standard of care chemotherapy for lung cancer which will consist of Carboplatin and Docetaxel.
Standard drug doses will be administered by intravenous infusion for up to 6 cycles of chemotherapy with each cyle lasting 3 weeks as per The American Society of Clinical Oncologists (ASCO) guidelines or until disease progression.
Exact dose amounts will be determined by the treating oncologists.

At disease progression all participants will be excluded from the trial and will recieve the standard of care treatment as directed by the participants oncologists.
Intervention code [1] 256370 0
Treatment: Drugs
Comparator / control treatment
The trial control group participants with lung cancer will undergo a biopsy and the biopsy material will be tested using the ATP-TCA assay but the results from the assay will not be used to guide chemotherapy and will be withheld from the treating oncologist as part of the blinding procedure. Control group participants will recive the normal standard of care for lung cancer.
Control group
Active

Outcomes
Primary outcome [1] 258310 0
The primary endpoint will be partial response (PR) rates as determined by RECIST criteria 1.1.
Timepoint [1] 258310 0
Following every two cycles of chemotherapy or until disese progression (for a maximum of six cycles).
Following completion of chemotheapy,every six weeks until disease progression
Secondary outcome [1] 264012 0
NIL
Timepoint [1] 264012 0
NIL

Eligibility
Key inclusion criteria
Inclusion Criteria:

. Participants with a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma aged >18 years.
. ECOG performance status of 0, 1 or 2.
. Stage IIIB or stage IV NSCLC or mesothelioma.
. Life expectancy of at least 3 months.
. One lesion amenable to thoroscopic biopsy.
. Presence of one measurable lesion as per RESIT criteria.
. No previous radiotherapy.
. Adequate bone marrow function.
1. Neutrophil count > 1.5 x 109/L
2. Platelets = 100 x 109/L
3. Haemoglobin > 100g/L
. Adequate hepatic function.
1. Bilirubin < upper limit for institution (except Gilberts disease)
2. ALT/AST = <1.5 x ULN for institution. In situations where the participant has liver metastasises an elevated <5 x ULN is acceptable
3. Alkaline phosphatase = <2.5 x ULN for institution.

. Adequate renal function.
1. Creatine within normal institutional limits OR
2. Creatine clearance >60 ml/min for participant with creatine levels above institutional normal range. (either measured or calculated using Cockroft-Gault formula)

. At least 2 million viable cancer cells recoverable from a biopsy or pleural aspiration.

. Participants must be able commence treatment within 7 days of ATP-TCA test result.

. Women of child-bearing potential must have a negative pregnancy test and agree to use an accepted and effective method of non-hormonal barrier contraception (barrier method of birth control, abstinence.

. An ability to understand and the willingness to sign a written informed consent document.

. Participants must be accessible for follow up.

. Participants must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:

. Participants may not be receiving any other investigational agents.

. Congestive heart failure (New York Heart Association (NYHA) Class III-IV) or history of congestive failure, unstable angina pectoris, myocardial infarction in the last 6 months, poorly controlled hypertension ( systolic>180mmHg or diastolic > 100mm Hg), clinically significant valvular disease, or high risk uncontrolled arrhythmias.

. History of significant neurologic or psychiatric disorders including psychotic disorders dementia or seizures that would prohibit the understanding and giving informed consent.

. Participants with dyspnoea at rest due to malignant or other disease who require supportive oxygen therapy.

. Participant who are pregnant or lactating at the time of registration to the trial

. Any active uncontrolled infection

. Any previous chemotherapy in the last 5 years for malignant disease.

. Any medical condition which in the investigators opinion makes the subject unsuitable for study participation

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)
Patient eligibility will be determined by the principal investigator before registration in the trial.
Patient registration numbers will be allocated sequentially as subjects enter the trial. If a patient discontinues from the trial, the patient registration number will not be reused.
Treatment and Allocation.
Subjects will be randomly allocated to one of the two treatment groups. Sealed envelopes will contain a label for one treatment group and the other will contain a label for the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelopes will be randomly mixed using computer generated pseudorandom numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 256879 0
Self funded/Unfunded
Name [1] 256879 0
Ballarat Cancer Research Centre
Country [1] 256879 0
Australia
Funding source category [2] 267417 0
Self funded/Unfunded
Name [2] 267417 0
Country [2] 267417 0
Primary sponsor type
Other Collaborative groups
Name
Ballarat Cancer Research Centre
Address
101 Drummond Street
C/O St. John of God Hospital
Ballarat
VIC
3350
Country
Australia
Secondary sponsor category [1] 256151 0
None
Name [1] 256151 0
Address [1] 256151 0
Country [1] 256151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258885 0
Ballarat health Services and St. John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 258885 0
101 Drummond St.
Ballarat
VICTORIA
3350
Ethics committee country [1] 258885 0
Australia
Date submitted for ethics approval [1] 258885 0
27/04/2010
Approval date [1] 258885 0
Ethics approval number [1] 258885 0

Summary
Brief summary
Lung cancer is the most common cause of cancer-related deaths. Although some improvements in the treatment of early stage lung cancer have occurred, the majority of participants still present with advanced (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapy, targeted therapies and radiotherapy. This study looks at whether response rates to an assay-directed chemotherapy regime - adenosine triphosphate tumour cell assay (ATP-TCA) - may be greater than in patients who are receiving current, standard chemotherapy for lung cancer.
Who is it for?
You may be eligible for this study if you have had a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma, are 18 years and above in age, have an ECOG performance status of 0, 1 or 2, and adequate bone marrow, hepatic and renal function as determined by clinical assessments. Trial details In this trial, you will be treated with either an assay-directed chemotherapy regime, ATP-TCA, or your physician’s choice of standard therapy for your condition. Which treatment you will receive will be determined by randomisation. If you are randomised to the ATP-TCA arm, you will be offered therapy based on your chemo-sensitivity profiles, from which a list of drugs that were positive on the ATP-TCA assay will be provided to your treating oncologist to decide the best first-line chemotherapy agents for you, provided in standard doses based on current clinical practice. The chemotherapy drugs that will be tested in the ATP-TCA assays include: Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). If you are randomised to the standard chemotherapy treatment, you will receive carboplatin and docetaxel administered every 3 weeks in standard doses. For both treatments, a total of 6 cycles will be administered providing there is evidence of stable disease or partial or complete response by the RECIST criteria. CT scans will be performed after the 3rd and 6th cycles of chemotherapy treatment. Should your disease progress past what is deemed suitable, your treating oncologist will then remove you from the study. Quality of-life assessments will be performed prior to cycle three of chemotherapy and following cycle The aim of this study is to test the hypothesis that the results of chemotherapy in non small cell lung cancer can be improved by predictive testing without an unacceptable increase in toxicity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31101 0
Address 31101 0
Country 31101 0
Phone 31101 0
Fax 31101 0
Email 31101 0
Contact person for public queries
Name 14348 0
Prof. George Kannourakis
Address 14348 0
Ballarat Cancer Research Centre
C/O St. John of God Hospital
Ballarat
VIC
3350
Country 14348 0
Australia
Phone 14348 0
+61 3 5320 2404
Fax 14348 0
+61 3 5320 2408
Email 14348 0
[email protected]
Contact person for scientific queries
Name 5276 0
Prof. George Kannourakis
Address 5276 0
Ballarat Cancer Research Centre
C/O St. John of God Hospital
Ballarat
VIC
3350
Country 5276 0
Australia
Phone 5276 0
+61 3 5320 2404
Fax 5276 0
+61 3 5320 2408
Email 5276 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

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