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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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)
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
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
82
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
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00193921