EUCTR2009-010093-38-DE进行中（未招募）1 期
Multi-institutional Phase I/II Study:Neoadjuvant chemoradiation with 5-FU (or capecitabine) and oxaliplatin combined with deep regional hyperthermia in locally advanced or recurrent rectal cancer - HyRec Trial
Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. Dr. h. c. Jürgen Schüttler0 个研究点开始时间: 2012年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Age = 18 years
- •Histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) or locally advanced adenocarcinoma of the rectum (UICC stage IIB-IV); distant oligo-metastases may be present.
- •ECOG-performance status < 2
- •Sufficient bone marrow function: WBC > 3,5 x 109/l, Neutrophil granulocytes > 1,5 x 109/l, Platelets > 100 x 109/l, Hemoglobin > 10 g/dl
- •Sufficient liver function:, Bilirubin < 2,0 mg%, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal
- •Serum creatinine < 1,5 mg%, glomerular filtration rate (or comparable test) > 50 ml/min
- •Signed study-specific consent form prior to therapy
- •Fertile patients must use effective contraception during and for 6 months after study treatment
- •Considered fit for oxaliplatin and 5-FU-containing combination chemotherapy.
- •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 59
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
排除标准
- •Pelvic radiotherapy during the last 12 months
- •Pregnant or lactating/nursing women
- •Drug addiction
- •On-treatment participation on other trials
- •Active intractable or uncontrollable infection
- •Prior or concurrent malignancy (= 5 years prior to enrolment in study) except rectal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
- •Chronic diarrhea (> NCI CTC-Grad 1)
- •Chronic inflammatory disease of the intestine
- •Collagen vascular disease
- •The presence of congenital diseases with increased radiation sensitivity, for example ataxia teleangiectatica, or similar
- •Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- •Myocardial infarction within the past 12 months
- •Congestive heart failure
- •Complete bundle branch block
- •New York Heart Association (NYHA) class III or IV heart disease
- •Known allergic reactions on study medication
- •Cardiac pacemaker
- •Disease that would preclude chemoradiation or deep regional hyperthermia
- •Any metal implants (with exception of non-clustered marker clips)
- •Psychological, familial, sociological, or geographical condition that would preclude study compliance
- •Patients deemed technically unsatisfactory for deep regional hyperthermia
- •Cardiac symptoms (> NCI CTC Grade 1) due to pre-treatment with fluoropyrimidines
- •Neurological symptoms (> NCI CTC Grade 1) due to pre-treatment with oxaliplatin
- •Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Oral anticoagulation
研究者
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