临床试验/2024-517928-19-00

2024-517928-19-00招募中2 期

Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group

Universitaetsklinikum Tuebingen AöR4 个研究点分布在 1 个国家目标入组 89 人开始时间: 2024年10月11日最近更新: 2025年2月25日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 89
试验地点: 4
主要终点: The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者: 是

入选标准

•Male and female patients with histologically confirmed diagnosis of rectalcancer localized 0 – 12 cm from the anocutaneous line as measured byrigid rectoscopy (i.e. lower and middle third of the rectum) Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal stagingaccording to “SOP MRI” Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magneticresonance imaging (MRI) of the pelvis is the mandatory local stagingprocedure. Cross-sectional imaging of the abdomen and chest to exclude distantmetastases. Aged at least 18 years. No upper age limit. WHO/ECOG Performance Status ≤ 1 Adequate hematological, hepatic, renal and metabolic function parameters:o Leukocytes ≥ 3.000/mm^3o ANC ≥ 2.000/mm^3o Platelets ≥ 100.000/mm^3 Hb > 9 g/dlo Serum creatinine ≤ 1.5 x upper limit of normalo Creatinin-Clearance ≥ 30 ml / mino Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit ofnormalo Informed consent of the patient Informed consent of the patient

排除标准

•Lower border of the tumor localised more than 12 cm from theanocutaneous line as measured by rigid rectoscopy cT4 tumors Positive lateral pelvic lymph nodes (s. SOP MRI) Distant metastases (to be excluded by CT scan of the thorax andabdomen) Preexisting fecal incontince for solid stool Preexisting peripheral sensory neuropathy with functional impairment Preexisting myelosuppression refleted by a neutrophil count < 2.000/mm^3and/or platelets < 100.000/mm^3 Severe impairment of kidney function with a Creatinin Clearance < 30ml/min) Prior antineoplastic therapy for rectal cancer Prior radiotherapy of the pelvic region Major surgery within the last 4 weeks prior to inclusion Subject pregnant or breast feeding, or planning to become pregnant within6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods ofcontraception according to the “Clinical trial fertility group”recommendations(http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 6 months (male or female) after the end oftreatment (adequate: combined hormonal contraception associated withinhibition of ovulation, progestogen-only hormonal contraceptionassociated with inhibition of ovulation, intrauterine device, intrauterinehormone-releasoing system, bilateral tubal occlusion, vasectomizedpartner1, sexual abstinence2). On-treatment participation in an interventional clinical study in the period 30days prior to inclusion Previous or current drug abuse Other concomitant antineoplastic therapy Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections,active, disseminated coagulation disorder, severe liver function disorders WHO/ECOG Performance Status > 1 Clinically significant cardiovascular disease (incl. myocardial infarction,unstable angina, symptomatic congestive heart failure, serious uncontrolledcardiac arrhythmia) ≤ 6 months before enrolment. Chronic diarrhea (> grade 1 according NCI CTCAE) Prior or concurrent malignancy ≤ 3 years prior to enrolment in study(Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage0-1), if the patient is continuously disease-free Known allergic reactions on study medication Known dihydropyrimidine dehydrogenase deficiency Medication inhibitors of the dihydropyrimidine dehydrogenase, such asBrivudin, Sorivudin and its analogues. Pernicious anemia or other anemias caused by Vitamin B-12 deficiency. Psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule(these conditions should be discussed with the patient before registration inthe trial). Additionally for hyperthermia cardiac pacemakers and metal implants in theproximity of the pelvis constitute a criterion for exclusion

结局指标

主要结局

The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.

次要结局

未报告次要终点

研究者

发起方

Universitaetsklinikum Tuebingen AöR

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Scientific

Universitaetsklinikum Tuebingen AöR

研究点 (4)

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