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Trial registered on ANZCTR


Registration number
ACTRN12608000588392
Ethics application status
Approved
Date submitted
3/11/2008
Date registered
21/11/2008
Date last updated
20/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer
Scientific title
A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy to improve progression free survival in advanced non-small cell lung cancer
Secondary ID [1] 280066 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NITRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced non-small cell lung cancer 3910 0
Condition category
Condition code
Cancer 4106 4106 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The addition of topical Nitroglycerin (patch) to standard chemotherapy (standard chemotherapy involves a combination of cisplatin or carboplatin with one of the following drugs - vinorelbine, paclitaxel, pemetrexed or gemcitabine). Each patient's specific treatment regime will be determined by the participant's doctor. Nitroglycerin is administered as a 25mg patch for 12 hours each day for 2 days before, the day of, and for two days after each chemotherapy injection. Treatment with the chemotherapy and Nitroglycerin will last for 6 treatment cycles (each cycle lasts for 3 weeks)
Intervention code [1] 3633 0
Treatment: Drugs
Comparator / control treatment
Standard Chemotherapy standard chemotherapy involves a combination of cisplatin or carboplatin with one of the following drugs - vinorelbine, paclitaxel, pemetrexed or gemcitabine. Each patient's specific treatment regime will be determined by the participant's doctor.Treatment with the chemotherapy will last for 6 treatment cycles (each cycle lasts for 3 weeks)
Control group
Active

Outcomes
Primary outcome [1] 4998 0
Progression-free survival which is measured by regular CT (computerised tomography) scans prior to treatment, every six weeks during chemotherapy, and every two months after chemotherapy until the lung cancer has progressed
Timepoint [1] 4998 0
After 460 progression events have occurred over all of the participants in the study (after 460 patients have shown progression of their lung cancer)
Secondary outcome [1] 8440 0
Overall survival which will be measured by regular visits to the hospital throughout chemotherapy, and then visits every two months after chemotherapy.
Timepoint [1] 8440 0
At the end of the study

Eligibility
Key inclusion criteria
Confirmed diagnosis of stage III or IV non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate bone marrow, kidney and liver function
Radiotherapy completed at least 1 week before randomisation
Patient is willing and able to comply with protocol requirements
Patient has completed quality of life questionnaires or is unable to complete due to illiteracy, language or limited vision
Female patients of childbearing potential must be willing to use adequate contraception
Plan to start chemotherapy within 8 days of randomisation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Untreated brain or meningeal metastases
Life expectancy less than 3 months
Any prior systemic therapy for advanced non-small cell lung cancer
History of previous or concomitant malignancies at other sites within the last 5 years
On nitrates, dihydroergotamine or phosphodiesterase inhibitors
History of allergic disease or reactions likely to be exacerbated by nitroglycerin
Uncontrolled cardiovascular disease
Other concomitant medical problems which would limit compliance with the study procedures or expose the patient to unacceptable risk
Active and uncontrolled infections

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)
Enrolment will be performed at the hospital and randomisation will be performed centrally at the University of Sydney Clinical Trials Centre by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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,VIC,QLD,SA,WA,TAS
Recruitment postcode(s) [1] 5037 0
2042
Recruitment postcode(s) [2] 5038 0
2031
Recruitment postcode(s) [3] 5039 0
2139
Recruitment postcode(s) [4] 5040 0
2170
Recruitment postcode(s) [5] 5041 0
2340
Recruitment postcode(s) [6] 5042 0
2200
Recruitment postcode(s) [7] 5043 0
2450
Recruitment postcode(s) [8] 5044 0
2250
Recruitment postcode(s) [9] 5045 0
2480
Recruitment postcode(s) [10] 5046 0
2485
Recruitment postcode(s) [11] 5047 0
2747
Recruitment postcode(s) [12] 5048 0
2350
Recruitment postcode(s) [13] 5049 0
2444
Recruitment postcode(s) [14] 5050 0
2305
Recruitment postcode(s) [15] 5051 0
3065
Recruitment postcode(s) [16] 5052 0
3181
Recruitment postcode(s) [17] 5053 0
3550
Recruitment postcode(s) [18] 5054 0
3220
Recruitment postcode(s) [19] 5055 0
3280
Recruitment postcode(s) [20] 5056 0
4814
Recruitment postcode(s) [21] 5057 0
4870
Recruitment postcode(s) [22] 5058 0
4560
Recruitment postcode(s) [23] 5059 0
4032
Recruitment postcode(s) [24] 5060 0
4033
Recruitment postcode(s) [25] 5061 0
5011
Recruitment postcode(s) [26] 5062 0
6009
Recruitment postcode(s) [27] 5063 0
6000
Recruitment postcode(s) [28] 5064 0
7000
Recruitment outside Australia
Country [1] 1325 0
New Zealand
State/province [1] 1325 0
Christchurch

Funding & Sponsors
Funding source category [1] 4097 0
Charities/Societies/Foundations
Name [1] 4097 0
WA Cancer Council
Address [1] 4097 0
46 Ventnor Avenue
West Perth 6005 WA
Country [1] 4097 0
Australia
Funding source category [2] 4098 0
Charities/Societies/Foundations
Name [2] 4098 0
QLD Cancer Council
Address [2] 4098 0
553 Gregory Terrace
Fortitude Valley Qld 4006
Country [2] 4098 0
Australia
Funding source category [3] 4099 0
Charities/Societies/Foundations
Name [3] 4099 0
NSW Cancer Council
Address [3] 4099 0
153 Dowling Street
Woolloomooloo, NSW 2011
Country [3] 4099 0
Australia
Funding source category [4] 284817 0
Government body
Name [4] 284817 0
Cancer Australia
Address [4] 284817 0
Level 14, 300 Elizabeth Street, SURRY HILLS NSW 2010
Country [4] 284817 0
Australia
Funding source category [5] 289731 0
Government body
Name [5] 289731 0
NHMRC
Address [5] 289731 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [5] 289731 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 3690 0
None
Name [1] 3690 0
Address [1] 3690 0
Country [1] 3690 0
Other collaborator category [1] 457 0
Other Collaborative groups
Name [1] 457 0
Australasian Lung Cancer Trials Group
Address [1] 457 0
PO Box 847
Lutwyche QLD 4030
Country [1] 457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6170 0
NSW Cancer Institute Ethics Committee
Ethics committee address [1] 6170 0
PO Box 41
Alexandria NSW 1435
Ethics committee country [1] 6170 0
Australia
Date submitted for ethics approval [1] 6170 0
Approval date [1] 6170 0
09/10/2008
Ethics approval number [1] 6170 0
2008C/08/059
Ethics committee name [2] 291466 0
Sydney Local Health District HREC (RPAH ZONE)
Ethics committee address [2] 291466 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [2] 291466 0
Australia
Date submitted for ethics approval [2] 291466 0
09/10/2013
Approval date [2] 291466 0
14/10/2013
Ethics approval number [2] 291466 0
X13-0165 & HREC/13/RPAH/418

Summary
Brief summary
This study will evaluate the efficacy of adding the drug, nitroglycerin, to first line chemotherapy for advanced non-small cell lung cancer.

Who is it for?
You may be eligible to join this study if you are 18 years or above and have a confirmed diagnosis of stage III or IV non-small cell lung cancer. Radiotherapy should have been completed at least one week before commencing treatment in this study.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups undergo 6 x 3 week treatment cycles of standard chemotherapy determined by their doctor. In addition, participants in group one will receive nitroglycerin administered as a 25mg patch for 12 hours each day for 2 days before, the day of, and for two days after each chemotherapy injection.

Participants will undergo regular visits to the hospital and undergo CT scans prior to treatment, every six weeks during chemotherapy, and every two months after chemotherapy until the lung cancer has progressed. This will help determine which treatment is more effective in terms of progression-free survival and overall survival.
Trial website
Trial related presentations / publications
A. Davidson, A.-S. Veillard, A. Tognela, M. M. K. Chan, B. G. M. Hughes, M. Boyer, K. Briscoe, S. Begbie, E. Abdi, C. Crombie, J. Long, A. Boyce, C. R. Lewis, S. Varma, A. Broad, N. Muljadi, S. Chinchen, D. Espinoza, X. Coskinas, N. Pavlakis, M. Millward, and M. R. Stockler on behalf of the Australasian Lung cancer Trials Group (ALTG). A phase III randomized trial of adding topical nitroglycerin to first-line chemotherapy for advanced nonsmall-cell lung cancer: the Australasian lung cancer trials group NITRO trial. Ann Oncol (2015) 26 (11): 2280-2286 first published online September 7, 2015
Public notes

Contacts
Principal investigator
Name 29086 0
A/Prof Andrew Davidson
Address 29086 0
Royal Perth Hospital
Medical Oncology
Wellington St, Perth, WA 6000
Country 29086 0
Australia
Phone 29086 0
+61 8 9224 2334
Fax 29086 0
Email 29086 0
andrew.davidson@health.wa.gov.au
Contact person for public queries
Name 12243 0
Mr Nitro trial coordinator / data manager
Address 12243 0
National Health and Medical Research Centre (NHMRC) Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 12243 0
Australia
Phone 12243 0
+61 2 9562 5000
Fax 12243 0
+61 2 9562 5094
Email 12243 0
nitro@ctc.usyd.edu.au
Contact person for scientific queries
Name 3171 0
A/Prof Andrew Davidson
Address 3171 0
Medical Oncology
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 3171 0
Australia
Phone 3171 0
+61 8 9224 2334
Fax 3171 0
+61 8 9224 3126
Email 3171 0
andrew.davidson@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary