To determine the efficacy and safety of adding transdermal nitroglycerin to first line chemotherapy for advanced NSCLC.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression-free survival.
Secondary outcome
Overall survival, objective tumour response rates, adverse events, quality of
life.
Background summary
In this study the efficacy and safety of the addition of nitroglycerin patches
to standard treatment with chemotherapy for advanced non-small cell lung cancer
will be assessed. The objective of this treatment is to reduce the disease
progression or to stop it temporarily.
Often there is a shortage of oxygen In the tumor. This stimulates the formation
of new blood vessels in an attempt to increase the amount of oxygen in the
tumor. This might counteract the efficacy of the chemotherapy.
Nitroglycerin (NTG) is a vasodilator. It might enhance the blood flow to the
tumor en might thus reduce the lack of oxygen en reduce the stumulation of new
blood vessel formation. This might be favorable for the treatment result. The
vasodilation by NTG might also improve the accessibility of the tumor for
chemotherapy. This might positively influence the effects of treatment. This
study is being performed in order to evaluate whether the addition of NTG does
indeed bring these beneficial effects.
NTG is already used for many decades as a medicine, mainly by the caridologist.
It is not being used in the treatment of cancer. The drug has been approved
(registered) by the Dutch authorities for the treatment of certain cardiac
diseases.
Study objective
To determine the efficacy and safety of adding transdermal nitroglycerin to
first line chemotherapy for advanced NSCLC.
Study design
Open, randomized phase III study. Treatment with standard chemotherapy. Choice
by the treating physician:
1. Cisplatin plus vinorelbine
2. Carboplatin plus gemcitabine
3. Carboplatin plus paclitaxel
4. Cisplatin or carboplatin plus pemetrexed
Randomization to treatment with or without Transiderm-Nitro 5 (25 mg, 10cm2).
The NTG patches will be used (during 12h per day) during every chemotherapy
cycle during 5 days: from 2 days prior to the chemotherapy infusion day up to
and including the second day after chemotherapy.
Treatment duration: as long as chemotherapy is continued. Follow-up for
survival.
Intervention
Treatment with nitroglycerin patches.
Study burden and risks
Risk: Adverse events (mainly headache) of nitroglycerin.
Burden: In line with standard treatment with the following exceptions:
Diary for entering times of application and removal of NTG patches.
Luijbenstraat 15
's Hertogenbosch 5211 BR
NL
Luijbenstraat 15
's Hertogenbosch 5211 BR
NL
Listed location countries
Age
Inclusion criteria
1. Stage III or IV non-small cell lung carcinoma. Measurable disease is not required.
2. ECOG performance status of 0, 1 or 2.
3. Radiotherapy completed at least 1 week before randomisation.
4. At least 18 years of age.
5. Adequate contraception for 30 days prior to drug administration for females of childbearing potential.
Exclusion criteria
1. Untreated brain or meningeal metastases.
2. Life expectancy less than 3 months.
3. Any prior systemic therapy for advanced NSCLC. Adjuvant chemotherapy for NSCLC completed more than 12 months before randomisation is allowed.
4. On nitrates, dihydroergotamine or phosphodiesterase inhibitors.
5. Uncontrolled cardiovascular disease.
6. Pregnancy, lactation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002050-78-NL |
| CCMO | NL45133.068.13 |
| Other | Victorian Cancer Trials Link; ACTRN12608000588392 |