碳离子放射治疗作为非转移性胰腺癌的确定性治疗：前瞻性 II 期 PACK 研究方案。
Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective phase II PACK-study.
机构信息
Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
出版信息
BMC Cancer. 2020 Oct 1;20(1):947. doi: 10.1186/s12885-020-07434-8.
BACKGROUND
Radiotherapy is known to improve local tumor control in locally advanced pancreatic cancer (LAPC), although there is a lack of convincing data on a potential overall survival benefit of chemoradiotherapy over chemotherapy alone. To improve efficacy of radiotherapy, new approaches need to be evolved. Carbon ion radiotherapy is supposed to be more effective than photon radiotherapy due to a higher relative biological effectiveness (RBE) and due to a steep dose-gradient making dose delivery highly conformal.
METHODS
The present Phase II PACK-study investigates carbon ion radiotherapy as definitive treatment in LAPC as well as in locally recurrent pancreatic cancer. A total irradiation dose of 48 Gy (RBE) will be delivered in twelve fractions. Concurrent chemotherapy is accepted, if indicated. The primary endpoint is the overall survival rate after 12 months. Secondary endpoints are progression free survival, safety, quality of life and impact on tumor markers CA 19-9 and CEA. A total of twenty-five patients are planned for recruitment over 2 years.
DISCUSSION
Recently, Japanese researches could show promising results in a Phase I/II-study evaluating chemoradiotherapy of carbon ion radiotherapy and gemcitabine in LAPC. The present prospective PACK-study investigates the efficacy of carbon ion radiotherapy in pancreatic cancer at Heidelberg Ion Beam Therapy Center (HIT) in Germany.
TRIAL REGISTRATION
The trial is registered at ClinicalTrials.gov: NCT04194268 (Retrospectively registered on December, 11th 2019).
背景
放疗已知可改善局部晚期胰腺癌（LAPC）的局部肿瘤控制，尽管在化学放疗比单独化疗可能具有总体生存获益方面缺乏令人信服的数据。为了提高放疗的疗效，需要发展新的方法。由于相对生物学效应（RBE）较高，并且由于剂量梯度陡峭，使剂量分布高度适形，碳离子放疗被认为比光子放疗更有效。
方法
目前的 II 期 PACK 研究调查了碳离子放疗作为 LAPC 以及局部复发性胰腺癌的确定性治疗。将以 12 个分次给予 48Gy（RBE）的总照射剂量。如果需要，可同时接受化疗。主要终点是 12 个月后的总生存率。次要终点是无进展生存期、安全性、生活质量以及对肿瘤标志物 CA 19-9 和 CEA 的影响。计划在 2 年内招募 25 名患者。
讨论
最近，日本的研究人员在一项评估 LAPC 中碳离子放疗和吉西他滨的放化疗的 I/II 期研究中取得了有希望的结果。目前的前瞻性 PACK 研究在德国海德堡离子束治疗中心（HIT）调查了碳离子放疗在胰腺癌中的疗效。
试验注册
该试验在 ClinicalTrials.gov 注册：NCT04194268（于 2019 年 12 月 11 日回顾性注册）。
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