Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000519550
Ethics application status
Approved
Date submitted
22/12/2003
Date registered
22/12/2003
Date last updated
30/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chemoradiotherapy in patients with localised lung cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 03.07 - A randomised phase II study of two regimens of palliative chemoradiation therapy (Vinorelbine and cisplatin OR Gemcitabine) in the management of locally advanced and metastatic non-small lung cancer to improve response rate.
Secondary ID [1] 45 0
ClinicalTrials.gov: NCT00193921
Secondary ID [2] 46 0
National Clinical Trials Registry: NCTR464
Universal Trial Number (UTN)
Trial acronym
TROG 03.07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced and metastatic non-small cell lung cancer. 42 0
Condition category
Condition code
Cancer 49 49 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: External beam radiation, 40Gy in 20 fractions/5 times per week plus Vinorelbine, IV, 25mg/m square, days 1, 8, 22 and Cisplatin 20mg/m cubed, IV, weekly. Subjects receive this treatment over 1 month (4 weeks).
Intervention code [1] 1298 0
Treatment: Drugs
Comparator / control treatment
Arm 2: External Beam radiation. 30Gy in 15 fractions/5 times per week plus Gemcitabine, 200mg, IV days 1, 8 and 15. Subjects receive this treatment over 3 weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 79 0
1. Objective response rate (RECIST criteria).
Timepoint [1] 79 0
Response will be assessed at 6 weeks post the completion of chemoradiotherapy.
Primary outcome [2] 80 0
2. Symptomatic response rate.
Timepoint [2] 80 0
Will be assessed at baseline, at 3 and 6 weeks post chemoradiotherpay and at follow up every 3 months until death.
Primary outcome [3] 81 0
3. The feasibility and problems encountered with protocol compliance.
Timepoint [3] 81 0
When study is complete Expected duration is 2 years.
Primary outcome [4] 82 0
4. Toxicity of both treatments.
Timepoint [4] 82 0
Weekly during chemoradiotherapy, weekly for the first 3 weeks after and at the 6 week mark post chemoradiotherapy and then every 3 months until death.
Secondary outcome [1] 155 0
1. Progression free survival.
Timepoint [1] 155 0
Time interval from date of randomisation to objective documentation of tumour progression or death due to tumour progression.
Secondary outcome [2] 156 0
2. Quality of Life.
Timepoint [2] 156 0
Baseline, at 3 and 6 weeks post chemoradiotherpay and at follow up every 3 months until death.

Eligibility
Key inclusion criteria
Histologically or cytologically proven non-small cell lung cancer.- Planned high dose palliative radiation therapy for locoregional control. Examples include patients with: a) Stage I – IIIB disease with: -disease technically unsuitable for radical therapy, or -weight loss in excess of 10%, or -concurrent medical illness b)Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a Flurodeoxyglucose-Positron Emission Tomography (FDG-PET) only solitary metastasis.- All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.- No prior radiotherapy or chemotherapy for non-small cell lung cancer. - European Cooperative Ooncology Group performance status 0, 1.- Adequate hepatic, bone marrow and renal function.- If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.- Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unable to receive all therapy as an outpatient.- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.- Receiving treatment with another investigational agent.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer
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
1/02/2003
Actual
4/12/2003
Date of last participant enrolment
Anticipated
Actual
14/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 69 0
Charities/Societies/Foundations
Name [1] 69 0
Multi-State Cancer Council Grant (Australian Capital Territory, Queensland)
Country [1] 69 0
Australia
Primary sponsor type
Individual
Name
Bryan Burmeister
Address
Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 56 0
Other Collaborative groups
Name [1] 56 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 56 0
Edith St Waratah NSW 2298
Country [1] 56 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 515 0
Murray Valley Private Hospital
Ethics committee address [1] 515 0
Ethics committee country [1] 515 0
Australia
Date submitted for ethics approval [1] 515 0
Approval date [1] 515 0
01/12/2003
Ethics approval number [1] 515 0
Ethics committee name [2] 516 0
RadOnc VIC - Frankston Private Hospital
Ethics committee address [2] 516 0
Ethics committee country [2] 516 0
Australia
Date submitted for ethics approval [2] 516 0
Approval date [2] 516 0
Ethics approval number [2] 516 0
Ethics committee name [3] 517 0
Premion Tugun - John Flynn Private
Ethics committee address [3] 517 0
Ethics committee country [3] 517 0
Australia
Date submitted for ethics approval [3] 517 0
Approval date [3] 517 0
Ethics approval number [3] 517 0
Ethics committee name [4] 518 0
Calvary Mater Newcastle
Ethics committee address [4] 518 0
Ethics committee country [4] 518 0
Australia
Date submitted for ethics approval [4] 518 0
Approval date [4] 518 0
Ethics approval number [4] 518 0
Ethics committee name [5] 519 0
Mater QRI
Ethics committee address [5] 519 0
Ethics committee country [5] 519 0
Australia
Date submitted for ethics approval [5] 519 0
Approval date [5] 519 0
Ethics approval number [5] 519 0
Ethics committee name [6] 520 0
Peter MacCallum Cancer Centre
Ethics committee address [6] 520 0
Ethics committee country [6] 520 0
Australia
Date submitted for ethics approval [6] 520 0
Approval date [6] 520 0
Ethics approval number [6] 520 0
Ethics committee name [7] 521 0
Princess Alexandra Hospital
Ethics committee address [7] 521 0
Ethics committee country [7] 521 0
Australia
Date submitted for ethics approval [7] 521 0
Approval date [7] 521 0
Ethics approval number [7] 521 0
Ethics committee name [8] 522 0
Townsville Hospital
Ethics committee address [8] 522 0
Ethics committee country [8] 522 0
Australia
Date submitted for ethics approval [8] 522 0
Approval date [8] 522 0
Ethics approval number [8] 522 0

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

Contacts
Principal investigator
Name 35791 0
Prof Bryan Burmeister
Address 35791 0
Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
Country 35791 0
Australia
Phone 35791 0
+61 7 3240 6584
Fax 35791 0
Email 35791 0
[email protected]
Contact person for public queries
Name 10487 0
Sharon Cox
Address 10487 0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 10487 0
Australia
Phone 10487 0
+61 7 3240 2007
Fax 10487 0
Email 10487 0
[email protected]
Contact person for scientific queries
Name 1415 0
Bryan Burmeister
Address 1415 0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 1415 0
Australia
Phone 1415 0
+61 7 3240 6584
Fax 1415 0
Email 1415 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.