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临床试验/NCT04546243
NCT04546243
已完成
不适用

A Retrospective Study Investigating Survival for High-grade Osteosarcoma Patients Who Had Achieved First Complete Surgical Remission (SCR) During Combined-modality Therapy in Two Hospitals Affiliated to Peking University

Peking University People's Hospital2 个研究点 分布在 1 个国家目标入组 127 人2020年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Osteosarcoma Metastatic
发起方
Peking University People's Hospital
入组人数
127
试验地点
2
主要终点
event-free survival
状态
已完成
最后更新
5年前

概览

简要总结

According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Resection of pulmonary metastases from osteosarcoma is a treatment option which has been shown to correlate with survival benefit and cure in select individuals. These patients are best addressed in a multidisciplinary fashion, with the involvement of a thoracic surgeon with experience in pulmonary metastasectomy. At the same time, the goal of surgical resection of pulmonary metastases from osteosarcoma is to render the patient completely disease free. "Tumor debulking" or "cytoreductive surgery" with incomplete resection has not demonstrated any survival benefit for patients with pulmonary metastases. Thus open thoracotomy is more preferred than VATS. However over the last decade in China, thoracotomy has not been adopted generally. More patients had chosen VATS or even hypo-fractionation radiotherapy, such as gamma knife, cyber knife and so on as a local treatment method. This study aims to investigate the survival of consecutive patients who had achieved a first complete surgical remission (CR) during combined-modality therapy on neoadjuvant or adjuvant PKUPH-OS protocol so as to discuss reasonable local therapy for resectable pulmonary osteosarcoma metastatic lesions.

注册库
clinicaltrials.gov
开始日期
2020年1月1日
结束日期
2020年11月1日
最后更新
5年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Histologically confirmed high-grade osteosarcoma reviewed by the Pathology Committee of Peking University People's Hospital
  • Pulmonary nodules by Chest CT confirmed by later scan as pulmonary metastasis
  • A first complete remission (CR) had been achieved
  • Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol as well as local therapy of all operable lesions

排除标准

  • Lost to follow up
  • Patients with severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction\<50%, and hypertension that could not be well controlled with antihypertensive drugs.

结局指标

主要结局

event-free survival

时间窗: 2 year

from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up

次要结局

  • local recurrence rate(2 year)
  • overall survival(5 year)

研究点 (2)

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