NL-OMON50770招募中2 期
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a randomized phase II clinical trial - SCOPES
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 168 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
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 thethe head and neck area, trunk or chest wall or
- •extremities, for which the standard treatment is a combination of and
- •radiotherapy 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);
- •Absence of regional and/or distant disease. Patients must be staged by at
- •least a CT scan of the chest Staging may also be performed by FDG-PET scanning
- •and or total body MRI scans. Patients with an uncertain metastatic status (e.g.
- •small indifferent lung nodules) and patients with a low metastatic burden not
- •precluding the application of both preoperative radiotherapy and definitive
- •surgery, are allowed to participate;
- •WHO Performance Status <= 2;
- •Able and willing to undergo preoperative radiotherapy;
- •Able and willing to undergo definitive surgery;
- •Able and willing to comply with regular follow-up visits;
- •Able and willing to complete patient reported outcome questionnaires
- •(health-related quality of life and cost effectiveness);
- •Able and willing to undergo randomization;
- •Age >= 18 years;
- •Signed written informed consent
排除标准
- •Prior malignancies; except another malignancy and disease-free for >= 5 years,
- •or completely resected non-melanomatous skin carcinoma or successfully treated
- •in situ carcinoma;
- •Patients with recurrent sarcomas who underwent prior radiotherapy to the
- •target lesion (if the primary sarcoma was managed by surgery only and no
- •perioperative RT, patients are eligible);
- •Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric
- •and adult), osteosarcomas;
- •Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
- •schedule; those conditions should be discussed with the patient before
- •registration in the trial;
- •Female patients who are pregnant;
- •Intention to perform an isolated limb perfusion, instead of a tumor resection;
- •Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and
- •definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed);
研究者
相似试验
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
已完成
不适用
A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancerow rectal cancerJPRN-UMIN000023361Cancer Institute Hospital of Japanese Foundation for Cancer Research28
招募中
2 期
Radiotherapy of soft tissue sarcomaIRCT20180919041070N3Iran University of Medical Sciences80
进行中（未招募）
不适用
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue SarcomasSoft Tissue SarcomasNCT04425967The Netherlands Cancer Institute168
已完成
不适用
Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)Colorectal cancerRectal cancerCancerISRCTN56463377Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)760