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临床试验/NCT02803151
NCT02803151Unknown不适用

A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
59
试验地点
2
主要终点
Local control (Response Evaluation Criteria In Solid Tumors version 1.1)

研究概览

简要总结

Lymph node metastasis is one of the most common sites to develop disease recurrence or progression after initial local treatment for primary solid malignancies or systemic treatment for advanced metastases. No specific treatment modality has been established as the standard therapy. Systemic therapy is usually considered since lymphadenopathy is considered as a sign of disease dissemination though aggressive local treatment, including surgical lymphoadenectomy or radical radiotherapy might result in long-term survival in selected patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of radiation targeted to a pathological entity and delivered in a few fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. The radiobiology of SABR has been shown to be very favorable for tumor control. Clinical experiences suggested that SABR might offer excellent in-field tumor control with low toxicity profile in selected patients, although the majority of reports are retrospective and include small patients series with heterogeneous tumor sites and dose-fractionation schedules.

At present, there is lack of validated prognostic factors to identify the patients who might benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the present study is aimed to provide a better understanding about utilization of SABR for metastatic lymph node(s). The associated translational researches will also advance our knowledge in the immune system reactions to SABR.

详细描述

This is a single institutional, single-arm, phase II trial to assess the local control rate of oligo-metastatic or oligo-progressive lymph node treated by stereotactic ablative radiotherapy at 1 year.

Patients with pathologically proven non-hematopoietic malignancy patients with radiographic evidence of evaluable regional recurrent, oligo-metastatic or oligo-progressive lymph nodes are eligible for enrolment.

Stereotactic Ablative Radiotherapy:

The lymph node planning target volume (PTV) will receive the prescribed dose according to the assigned treatment group. The dose is prescribed such as 90-95% of PTV is covered by the prescription dose. If the critical structures exceed the defined dose limitation, a dose reduction method is applied as protocol defined. Dose inhomogeneity can exist within the clinical target volume (CTV).

Treatment will be delivered in six fractions to the target volume and given once per day, 2-3 fractions per week with no more than 2 daily consecutive fractions, over 2 to 2.5 weeks.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Stereotactic ablative radiotherapy

Experimental

Image-guided stereotactic ablative radiotherapy

干预措施: Stereotactic ablative radiotherapy (Radiation)

结局指标

主要结局

Local control (Response Evaluation Criteria In Solid Tumors version 1.1)

时间窗: 12 months

Number of participant with local progression of index metastatic lymph receiving stereotactic ablative radiotherapy, assessed on CT scan according to Response Evaluation Criteria In Solid Tumors version 1.1

次要结局

  • Patient reported outcome (Quality of Life questionnaire)(at 1, 3 months after radiotherapy, and every 3 month thereafter until unequivocal progression, hospice care, or death, assessed up to 12 months)
  • Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)(From date of radiotherapy until 90 days after radiotherapy starts)
  • Late toxicity (Common Toxicity Criteria for Adverse Events version 4)(From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months)
  • Metastatic nodal progression(From date of enrolment until the date of first documented metastatic nodal progression or date of death from any cause, whichever came first, assessed up to 60 months)
  • Overall survival(From date of enrollment until the date of death from any cause, assessed up to 60 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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