EUCTR2013-002050-78-NL进行中（未招募）不适用
A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced nonsmall cell lung cancer - NITRO TRIA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- VALT
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed diagnosis of a stage III or IV non-small cell lung carcinoma
- •(including cytology obtained by brushings, washings or needle aspirations; and/or sputum cytology
- •positive on at least 2 occasions). Patients with stage III disease must not be candidates for subsequent
- •surgery and/or chemoradiotherapy) [Refer to Appendix 3]. Measurable disease is not required.
- •2. ECOG performance status of 0, 1 or 2 at the time of randomisation [Appendix 4].
- •3. Adequate bone-marrow, renal and hepatic function as follows:
- •Haemoglobin = 100 g/l
- •Absolute neutrophil count =1.5 x 109/L
- •Platelet count =100 x 109/L
- •Serum bilirubin =1.5 times ULN (Upper Limit of Normal)
- •Alanine transaminase (ALT) =2.5 times ULN if liver metastases not evident <5 times
- •ULN if liver metastases are evident
- •Serum creatinine =1.5 times (ULN)
- •Calculated creatinine clearance = 50ml/min
- •4. Radiotherapy completed at least 1 week before randomisation (a 3-week gap is recommended for
- •radiation including significant volumes of lung or bone marrow).
- •5. The patient is willing and able to comply with the requirements of the protocol and will be accessible for
- •6. Has completed the HRQL questionnaires or is unable to complete them because of illiteracy,
- •insufficient english, or limited vision.
- •7. Patient is >18 years of age.
- •8. If the patient is female, then she must be either of non-childbearing potential (i.e. be post-menopausal,
- •or have a current tubal ligation, hysterectomy or oophorectomy) or if of childbearing potential, then she
- •must practice adequate contraception for 30 days prior to administration of study treatment, have a
- •negative pregnancy test (serum or urine) and continue such precautions during all study treatment
- •period and for 2 months after completion of chemotherapy.
- •9. Written informed consent
- •10. Plan to start chemotherapy within 8 days of randomisation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Untreated brain or meningeal metastases
- •2. Life expectancy less than 3 months.
- •3. Any prior systemic therapy for advanced non-small lung cancer including cytotoxic drugs, anti EGF or
- •anti VEGF drugs. Adjuvant chemotherapy for non-small cell lung cancer completed more than 12
- •months before randomisation is allowed.
- •4. History of previous or concomitant malignancies at other sites within the last 5 years. Exceptions:
- •Effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated
- •malignancy that has been in remission for over 5 years and highly likely to have been cured.
- •5. On nitrates, dihydroergotamine or phosphodiesterase inhibitors (e.g. sildenafil)
- •6. History of allergic disease or reactions likely to be exacerbated by nitroglycerin.
- •7. Uncontrolled cardiovascular disease, including symptomatic congestive cardiac failure, symptomatic
- •coronary artery disease, or clinically significant hypotension.
- •8. Other concurrent medical problems, unrelated to the malignancy, which would limit compliance with the
- •study procedures or expose the patient to unacceptable risk.
- •9. Active and uncontrolled infections
- •10. Psychiatric or addictive disorders that may compromise their ability to give informed consent, or to
- •comply with the trial procedures.
- •11. Any investigational or non-registered medicinal product within the 30 days preceding the first dose of
- •study medication, or plans to receive such a drug during the study period.
- •12. For female patients: the patient is pregnant or lactating.
研究者
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