A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer

Phase 3

Completed

• Conditions: Advanced non-small cell lung cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12608000588392
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-21
• Study Completion: 2015-01-19
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 372

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[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 Measures

Name	Time	Method
Overall survival which will be measured by regular visits to the hospital throughout chemotherapy, and then visits every two months after chemotherapy.[At the end of the study]