Trial registered on ANZCTR


Trial ID
ACTRN12605000169640
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
17/08/2005
Date last updated
17/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised pilot study to investigate the optimum timing of gemcitabine and concurrent radiation therapy after induction gemcitabine and carboplatin for locally advanced non-small cell lung cancer
Scientific title
A randomised pilot study assessing tumor response by investigating the optimum timing of gemcitabine and concurrent radiation therapy after induction gemcitabine and carboplatin for locally advanced non-small cell lung cancer
Secondary ID [1] 118 0
Pilot Lung Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced non-small cell lung cancer 264 0
Condition category
Condition code
Cancer 297 297 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised trial consisting of arms A and B. Both arms commence induction chemotherapy Day 1 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 8 Gemcitabine 1000mg/m2 Day 22 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 29 Gemcitabine 1000mg/m2 with Concurrent treatment, radiation and Gemcitabine treatment.
Arm A will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given 5 or more hours prior to the radiation. Arm B will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given within 3 hours or less prior to the radiation.
Intervention code [1] 190 0
Treatment: drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 349 0
Objective response rate within the irradiated volume
Timepoint [1] 349 0
6 weeks post treatment and 3 monthly follow ups until death or loss to follow-up.
Secondary outcome [1] 788 0
1. Toxicity
Timepoint [1] 788 0
Secondary outcome [2] 789 0
2. Progression-free survival
Timepoint [2] 789 0
Secondary outcome [3] 790 0
3. Overall survival
Timepoint [3] 790 0

Eligibility
Key inclusion criteria
Histologically or cytologically proven non-small cell lung cancer.-Planned moderate dose radiation therapy for locoregional control. -Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have solitary metastasis. If in the brain the metastasis must be operable-Patients must have measurable disease on imaging scans.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the sequencing was generated with Statview with a p value of .5 and n = 24
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
Active, not recruiting
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] 355 0
Commercial sector/Industry
Name [1] 355 0
Eli Lilly Australia PTY LTD
Address [1] 355 0
Country [1] 355 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 281 0
None
Name [1] 281 0
Nil
Address [1] 281 0
Country [1] 281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1327 0
Princess Alexandra Hospital Oncology/haematology/Radiation Research Unit
Ethics committee address [1] 1327 0
Ipswich road Woolloongabba Qld 4102
Ethics committee country [1] 1327 0
Australia
Date submitted for ethics approval [1] 1327 0
Approval date [1] 1327 0
Ethics approval number [1] 1327 0

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

Contacts
Principal investigator
Name 36072 0
Address 36072 0
Country 36072 0
Phone 36072 0
Fax 36072 0
Email 36072 0
Contact person for public queries
Name 9379 0
Associate Professor Bryan Burmeister
Address 9379 0
Oncology/Haematology/Radiation Research Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 9379 0
Australia
Phone 9379 0
+61 7 32406581
Fax 9379 0
+61 7 32402252
Email 9379 0
Bryan_Burmeister@health.qld.gov.au
Contact person for scientific queries
Name 307 0
Brenda Rosser
Address 307 0
Oncology/Haematology/Radiation Research Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 307 0
Australia
Phone 307 0
+61 7 32402130
Fax 307 0
+61 7 32402252
Email 307 0
Brenda_Rosser@health.qld.gov.au