EUCTR2018-002095-40-ES进行中（未招募）1 期
Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program.
Fundación de investigación de HM Hospitales0 个研究点目标入组 30 人开始时间: 2019年1月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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. Male or females, aged > or = 18 years.
- •2. Agree to participate and sign voluntary written ICF before any study specific
- •3. Patients with confirmed histopathological diagnosis of rectal cancer.
- •4. Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch & wait program.
- •5. Patients considered for neoadjuvant treatment according to usual clinical practice
- •may also be potential candidates.
- •6. ECOG performance status 0 or 1.
- •7. Patients who can receive radiotherapy and chemotherapy.
- •8. No prior or concurrent malignant disease unless in complete remission for more
- •than three years, except for adequately treated in situ carcinoma of the cervix, basal
- •or squamous skin cell carcinoma or in situ transitional bladder cell carcinoma.
- •9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy
- •test before study entry. Both women and men must agree to use a highly effective
- •contraceptive measure throughout the treatment period and for six months after
- •discontinuation of treatment.
- •10. Adequate hematologic function
- •11. Adequate hepatic function
- •12. Adequate renal function
- •13. No peripheral neuropathy (< Grade 2)
- •14. No known history of dihydropyrimidine dehydrogenase deficiency (DPD)
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Patients with ECOG performance status > or =2.
- •2. T1N0M0)or stage IV (TxNxM1) AJCC rectal cancer.
- •3. Any illness that the investigator considers will substantially increase the risk if the
- •patient participates in the study.
- •4. Pregnant or breast-feeding woman.
- •5. Chronically active hepatitis B or C virus infection.
- •6. Active uncontrolled infection.
- •7. History, within last year, or presence of unstable angina, myocardial infarction,
- •symptomatic congestive heart failure or asymptomatic left ventricular ejection
- •fraction < 50% (assessed by multiple-gated acquisition scan or equivalent by
- •ultrasound) or clinically significant valvular heart disease.
- •8. Peripheral neuropathy (> Grade 1)
- •9. Known history of dihydropyrimidine dehydrogenase deficiency (DPD)
- •10. Known or suspected reactions to any component of the study medication (5-FU,
- •leucovorin, irinotecan or oxaliplatin) or to components of similar chemical or
- •biologic composition.
- •11. Any phycological, familiar, sociological or geographical condition potentially
- •hampering compliance with the study protocol or follow-up schedule.
- •12. Concurrent participation in any other clinical trial likely to interfere with the
- •therapeutic schedule.
- •13. Patients that had received any previous treatment for their rectal cancer (surgery,
- •chemotherapy or radiotherapy).
研究者
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