None listed
Conditions
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.
Interventions
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 chemother
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)
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed