<!-- Alternate content for non-supporting browsers --> <h2>upgrade</h2> <h3>your browser</h3>
Home
Login
Contact us
Feedback
Register Trial
Trial Search
Latest News
FAQ
About Us
Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
083317
ACTR Number:
ACTRN12608000588392
Trial Status:
Registered
Date Submitted:
3/11/2008
Date Registered:
21/11/2008
Page 1
Public title:
A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer
Update:
Reason:
ANZCTR registration 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
Update:
Reason:
Secondary ID:
UTN:
Update:
Reason:
Trial acronym:
NITRO
Update:
Page 2
Health condition(s) or problem(s) studied:
Advanced non-small cell lung cancer
Condition category:
Condition code:
Cancer
Lung - Non small cell
Page 3
Description of intervention(s) / exposure:
The addition of topical Nitroglycerin (patch) to standard chemotherapy (standard chemotherapy involves a combination of two of the following drugs - vinorelbine, paclitaxel and 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)
Update:
Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
Standard Chemotherapy standard chemotherapy involves a combination of two of the following drugs - vinorelbine, paclitaxel and 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)
Update:
Reason:
Control group:
Active
Update:
Reason:
Page 4
Primary outcome:
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:
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:
Overall survival which will be measured by regular visits to the hospital throughout chemotherapy, and then visits every two months after chemotherapy.
Timepoint:
After 460 progression events have occurred over all of the participants in the study (after 460 patients have shown progression of their lung cancer)
Page 5
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
Update:
Reason:
Minimum Age:
18
Years
Update:
Reason:
Maximum Age:
No limit
Update:
Reason:
Gender:
Both males and females
Update:
Reason:
Healthy volunteers?
No
Update:
Reason:
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
Update:
Reason:
Page 6
Study type:
Interventional
Update:
Reason:
Purpose of the study:
Treatment
Update:
Allocation to intervention:
Randomised controlled trial
Update:
Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Enrolment and randomisation will be performed centrally by computer
Update:
Reason:
Describe the 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
Update:
Reason:
Masking / blinding:
Open (masking not used)
Update:
Reason:
Update:
Reason:
Assignment:
Parallel
Update:
Reason:
Other design features (specify):
Update:
Reason:
Type of endpoint(s):
Efficacy
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Page 7
Phase
Phase 3
Update:
Reason:
Anticipated or actual date of first participant enrolement:
10/01/2009
Update:
Reason:
Target sample size:
500
Update:
Reason:
Recruitment status:
Not yet recruiting
Update:
Reason:
Page 8
Funding source 1:
Charities/Societies/Foundations
Name:
WA Cancer Council
Address:
46 Ventnor Avenue West Perth 6005 WA
Country:
Australia
Funding source 2:
Charities/Societies/Foundations
Name:
QLD Cancer Council
Address:
553 Gregory Terrace Fortitude Valley Qld 4006
Country:
Australia
Funding source 3:
Charities/Societies/Foundations
Name:
NSW Cancer Council
Address:
153 Dowling Street Woolloomooloo, NSW 2011
Country:
Australia
Primary sponsor:
University
Update:
Reason:
Name:
University of Sydney
Update:
Reason:
Address:
Locked Bag 77 Camperdown NSW 1450
Update:
Reason:
Country:
Australia
Update:
Reason:
Secondary sponsor:
None
Name:
Address:
Country:
Other collaborator:
Other Collaborative groups
Name:
Australasian Lung Cancer Trials Group
Address:
PO Box 847 Lutwyche QLD 4030
Country:
Australia
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
NSW Cancer Institute Ethics Committee
Address:
PO Box 41 Alexandria NSW 1435
Country:
Australia
Date of approval:
9/10/2008
HREC Number:
2008C/08/059
Countries of recruitment:
Australia
Postcode:
2340, 2050, 2450, 2750, 2031, 2350, 2300, 4032, 4560, 4102, 4020
2000, 2009
Brief summary:
The aim of this trial is to determine the effects of adding transdermal nitroglycerin to first line chemotherapy.
The primary objective is to determine its effect on progression-free survival (PFS).
Secondary objectives are to determine its effects on:
Overall survival (OS),
Objective tumour response (OTR),
Adverse events (AE), and
Health-related quality of life (HRQL).
The underlying hypotheses are that addition of nitroglycerin will lead to an improvement in PFS and also
favourably affect OS, OTR and HRQL, and that adverse events will be infrequent and mild.
Update:
Reason:
Trial website:
Update:
Presentations / publication list:
Update:
Page 10
Contact person for public queries
Name:
Natalie Galbraith
Update:
Reason:
Address:
National Health and Medical Research Centre (NHMRC) Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 9562 5069
Update:
Reason:
Fax:
+61 2 9562 5094
Update:
Reason:
Email:
natalie.galbraith@ctc.usyd.edu.au
Update:
Reason:
Contact person for scientific queries
Name:
Dr Andrew Davidson
Update:
Reason:
Address:
Medical Oncology
Royal Perth Hospital
Wellington Street
Perth WA 6000
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 8 9224 2334
Update:
Reason:
Fax:
+61 8 9224 3126
Update:
Reason:
Email:
andrew.davidson@health.wa.gov.au
Update:
Reason:
Contact person responsible for updating information
Name:
Natalie Galbraith
Update:
Reason:
Address:
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 9562 5069
Update:
Reason:
Fax:
+61 2 9562 5094
Update:
Reason:
Email:
natalie.galbraith@ctc.usyd.edu.au
Update:
Reason:
