EUCTR2014-002063-14-ES进行中（未招募）1 期
Induction FOLFOX with or without Aflibercept followed by chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II randomized, multicenter, open label trial - RIA Study
GEMCAD (Grupo Español Multidisciplinar en Cáncer Digestivo)0 个研究点目标入组 180 人开始时间: 2014年8月6日最近更新:
适应症
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
- 180
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
入选标准
- •1) Signed and dated informed consent, and willing and able to comply with protocol requirement;
- •2) Male or female subjects with rectal cancer = 18 and <70 years of age;
- •3) High risk MRI-defined operable rectal cancer (with an inferior margin no more than 12 cm above the anal verge as assesed by MRI).
- •Presence of at least 1 of the following on high resolution, thin-slice MRI (3 mm):
- •Middle Third Tumors
- •a) Extramural vascular invasion (EMVI) positive
- •b) Extramural extension > 5 mms into perirectal fat
- •c) Mesorectal fascia (MRF) threatened or involved*
- •-mr T4***
- •Distal Third Tumors (?5 cm from anal verge)
- •- mrT3 tumor at or below levators
- •-T4 as above
- •*tumor or lymph node < 1 mm from the mesorectal fascia
- •**= 4 lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. = 4 nodes, whether enlarged or not, with a rounded, homogeneous appearance is thus not sufficient.
- •***T4a: overgrowth to an adjacent organ or structure or T4b: peritoneal involvement.
- •4) Histologically confirmed adenocarcinoma of the rectum. All other histological types are excluded;
- •5) ECOG Performance Status of = 1;
- •6) Hematological status: neutrophils (ANC) = 1.5x109/L; platelets = 100x109/L; hemoglobin = 9g/dL;
- •7) Adequate renal function: serum creatinine level <1.5 x upper limit of normality (ULN);
- •8) Adequate liver function: serum bilirubin = 1.5 x ULN, alkaline phosphatase <5xULN, AST/ALT < 3 x ULN;
- •9) Proteinuria <2+ (dipstick urinalysis) or = 1g/24hour;
- •10) Regular follow-up feasible;
- •11) For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior to starting study treatment;
- •12) Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1) Prior treatment with aflibercept;
- •2) History or evidence upon physical examination of metastasis;
- •3) Uncontrolled hypercalcemia;
- •4) Pre-existing permanent neuropathy (NCI grade ?2);
- •5) Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy;
- •6) Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy);
- •7) Treatment with any other investigational medicinal product within 28 days prior to study entry;
- •8) Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years;
- •9) Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days;
- •10) Pregnant or breastfeeding women;
- •11) Patients with known allergy to any excipient to study drugs;
- •12) History of myocardial infarction and/or stroke within 6 months prior to randomization;
- •Previous history of stable angina, uncontrolled arrhythmia, and acute coronary syndrome even if controlled with medication or with myocardial infarction within the last 12 months.
- •13) Bowel obstruction.
研究者
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