NCT02106312Unknown2 期
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 24
- 主要终点
- The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
研究概览
简要总结
To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.
详细描述
- A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
- Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above or equal to 18 years
- •Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
- •ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
- •Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
- •Written informed consent
排除标准
- •Prior radiotherapy to the target area.
- •Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
- •Pregnancy -
结局指标
主要结局
The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
时间窗: The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.
次要结局
未报告次要终点
研究者
研究点 (24)
Loading locations...
相似试验
尚未招募
不适用
DOse REduction of preoperatieve radiotherapyin MYxoid liposarcoma.(Dosis verlaging van de preoperatieve bestraling van myxoidliposarcomen).radiotherapy, myxoid liposarcoma, soft tissue sarcoma (radiotherapie, myxoid sarcomm en weke delen sarcoom)NL-OMON23428KI-AV10
尚未招募
2 期
Dose Reduction of preoperative radiotherapy in myxoid liposarcomaNL-OMON47519ederlands Kanker Instituut73
已完成
不适用
Study for Using Radiosurgery on Limited Metastases of Breast CancerBreast Cancer, MetastaticNCT00167414University of Rochester49
招募中
2 期
Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal MelanomaNCT05546827M.D. Anderson Cancer Center40
尚未招募
2 期
Preoperative short-term radiotherapy for primary resectable rectal cancer: Accelerated once daily (5x5Gy) versus accelerated hyperfractionated twice daily (12x2,5Gy b.i.d.) (ONCE-TWICE trial) A phase II single-blinded multi-institutional randomised studybowel cancerrectal cancer10017991NL-OMON29980niversitair Medisch Centrum Groningen210