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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00193921




Registration number
NCT00193921
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
4/08/2014

Titles & IDs
Public title
Chemoradiotherapy in Patients With Localised Lung Cancer
Scientific title
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
Secondary ID [1] 0 0
PMCC Protocol No. 03/85
Secondary ID [2] 0 0
TROG 03.07
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vinorelbine
Treatment: Other - High dose Radiotherapy
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Other - High Dose Radiotherapy

Experimental: A - Vinorelbine + cisplatin + high-dose palliative radiotherapy

Active Comparator: B - Gemcitabine + high-dose palliative radiotherapy


Treatment: Drugs: Vinorelbine
IV, 25mg/m2, days 1, 8, 22

Treatment: Other: High dose Radiotherapy
External beam radiation, 40 Gy/20#/5 per week

Treatment: Drugs: Gemcitabine
200mg (flat dose) IV days 1, 8, 15

Treatment: Drugs: Cisplatin
20mg/m2, IV, weekly

Treatment: Other: High Dose Radiotherapy
External beam radiation, 30 Gy/15#/5 per week

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (RECIST criteria)
Timepoint [1] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Primary outcome [2] 0 0
Symptomatic response rate
Timepoint [2] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Primary outcome [3] 0 0
The feasibility (i.e. % of patients who cannot complete the planned RT dose or who require a break for toxicity) and problems encountered with protocol compliance in the setting of a multi-institutional TROG study.
Timepoint [3] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Primary outcome [4] 0 0
Toxicity of both treatments
Timepoint [4] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Secondary outcome [2] 0 0
QOL as assessed by FACT-L version 4.
Timepoint [2] 0 0
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

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:

1. Stage I - IIIB disease with

- disease technically unsuitable for radical therapy, or · weight loss in
excess of 10%, or

- concurrent medical illness

2. Patients found to have a locally advanced thoracic disease suitable for radical
therapy but on work up are found to have a 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.

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



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [2] 0 0
Mater Misericordiae Hospital - Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [5] 0 0
The John Flynn Hospital - Tugun
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 0 0
Border Medical Oncology - Wondonga
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
4810 - Townsville
Recruitment postcode(s) [5] 0 0
4224 - Tugun
Recruitment postcode(s) [6] 0 0
- Frankston
Recruitment postcode(s) [7] 0 0
8006 - Melbourne
Recruitment postcode(s) [8] 0 0
- Wondonga

Funding & Sponsors
Primary sponsor type
Other
Name
Trans-Tasman Radiation Oncology Group (TROG)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Council Queensland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Victorian Cancer Council
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study compares 2 different methods of combined chemotherapy and radiotherapy for the
treatment of localised lung cancer in patients not suitable for surgery.

Hypothesis(es) to be tested:

1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +
high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting

2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +
high dose palliative radiotherapy in terms of feasibility in a multi-institutional
setting

3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity
profile relative to gemcitabine + high-dose palliative radiotherapy
Trial website
https://clinicaltrials.gov/show/NCT00193921
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Michael
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications