NL-OMON56068招募中不适用
Sarcomas and DDR-Inhibition; a neoadjuvant phase I combined modality study - SADDRIN-1 - SADDRIN-1
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed newly diagnosed intermediate to high grade soft
- •tissue sarcoma localized to the extremities or trunk- and chest wall, for which
- •the standard treatment is a combination of and RT and surgery (deep seated
- •and/or > 5cm in largest tumor diameter and/or an anticipated close resection
- •margin and/or grade II/III according to the FNCLCC definition);
- •Patients staged by at least a CT scan of the chest (and a CT scan of the
- •abdomen, if deemed indicated according to local practices, e.g. in case of a
- •myxoid liposarcoma). Staging may also be performed by FDG-PET scanning and or
- •total body MRI scans. This staging procedure should not reveal metastatic
- •disease. If, however, a low metastatic burden is detected such that this does
- •not preclude the application of both preoperative RT and definitive surgery,
- •patients are allowed to participate;
- •WHO Performance Status <= 2;
- •Able and willing to undergo preoperative RT;
- •Able and willing to undergo definitive surgery;
- •Able and willing to comply with regular follow-up visits;
- •Able and willing to swallow and retain oral medication;
- •Age >= 18 years;
- •Body weight >30kg;
- •Must have a life expectancy of at least 12 weeks;
- •Adequate organ function as defined in Table 4
- •Signed written informed consent prior to any study specific procedures or
排除标准
- •Pathological diagnosis
- •Patients with any type soft tissue sarcoma located above the clavicles;
- •Patients with recurrent sarcomas who underwent prior radiotherapy to the
- •target lesion (if the primary sarcoma was managed by surgery only and no
- •perioperative radiotherapy, patients are eligible);
- •Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric
- •and adult), bone sarcomas;
- •Concurrent therapies
- •Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and
- •definitive surgery is not allowed. (neoadjuvant chemotherapy before start of
- •study radiotherapy is allowed);
- •Intention to perform an isolated limb perfusion, instead of a tumor resection;
- •Radiotherapy treatment to more than 30% of the bone marrow or with a wide
- •field of radiation within 4 weeks of the first dose of study drug;
- •Medical History
- •Prior malignancies; except another malignancy and disease-free for >= 5 years,
- •or completely resected non-melanomatous skin carcinoma or successfully treated
- •in situ carcinoma;
- •Prior surgical procedure within 28 days prior to the first dose of
- •durvalumab, excluding minor surgical procedures e.g procedures only recuing
- •local anesthesia.
- •Past medical history of interstitial lung disease (ILD ), drug-induced ILD,
- •radiation pneumonitis which required steroid treatment, or any evidence of
- •clinically active interstitial lung disease;
- •History or presence of myopathy or raised CK >5 x ULN on 2 occasions at
- •screening. CK should not be measured following strenuous exercise or in the
- •presence of a plausible alternative cause of CK increase, which may confound
- •interpretation of the results. If CK levels are significantly elevated at
- •baseline (>5 x ULN) a confirmatory test should be carried out within 5 - 7
- •days. If the repeat test confirms a baseline CK >5 x ULN, treatment should not
- •be started;
- •History and/or presence of COVID-19: (a)Previous severe course of COVID-19
- •(ie, hospitalisation, extracorporeal membrane oxygenation, mechanically
- •ventilated), (b) Clinical signs and symptoms consistent with COVID-19, eg,
- •fever, dry cough, dyspnoea, sore throat, fatigue or confirmed current infection
- •by appropriate laboratory test within the last 4 weeks prior to screening;
- •Cardiac function
- •Cardiac dysfunction defined as: Myocardial infarction within six months of
- •study entry, NYHA Class II/III/IV heart failure, unstable angina or unstable
- •cardiac arrhythmias;
- •Any of the following cardiac criteria:
- •* Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3
- •electrocardiograms (ECGs) (QTc interval will be calculated using Fridericia*s
- •* Any clinically important abnormalities in rhythm, conduction or morphology of
- •resting ECG, e.g., complete left bundle branch block, third degree heart block;
- •* Any factors that increase the risk of QTc prolongation or risk of arrhythmic
- •events such as heart failure, hypokalemia, congenital long QT syndrome, family
- •history of long QT syndrome or unexplained sudden death under 40 years-of-age.
- •Patients stable on concomitant medications known to prolong the QT interval may
- •be allowed to participate in the study provided that their mean resting
- 另有 2 项未显示
研究者
相似试验
进行中（未招募）
1 期
Chemoradiotherapy at soft tissue sarcomassoft tissue sarcomasMedDRA version: 20.0Level: HLTClassification code 10041293Term: Soft tissue neoplasms malignant and unspecified NEC (excl sarcomas)System Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10024628Term: Liposarcomas malignantSystem Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10024190Term: LeiomyosarcomasSystem Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10016634Term: Fibrosarcomas malignantSystem Organ Class: 100000004864EUCTR2021-000042-17-NLetherlands Cancer Institute30
终止
1 期
Sarcomas and DDR-Inhibition; a Combined Modality StudySoft Tissue Sarcoma AdultNCT05116254The Netherlands Cancer Institute12
终止
1 期
Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue SarcomaSoft Tissue SarcomaNCT03116529University of Maryland, Baltimore22
已完成
1 期
Lycopene in Preventing Prostate Cancer in Healthy ParticipantsProstate CancerNCT00093561University of Illinois at Chicago
已完成
早期 1 期
Combination Chemotherapy in Treating Patients With SarcomaOvarian CancerSarcomaNCT00662233Mayo Clinic28