Ion therapy within the trimodal management of superior sulcus tumors: the INKA trial

BMC Cancer

Klaus Herfarth³  Jürgen Debus³  Meinhard Kieser¹  Michael Thomas²  Hendrik C Dienemann⁴  Stefan Rieken³  Henrik Hauswald³ 

[1]Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

[2]Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), University Hospital of Heidelberg, Heidelberg, Germany

[3]Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany

[4]Department of Thoracic Surgery, Thoraxklinik, University Hospital of Heidelberg, Heidelberg, Germany

关键词: Lung cancer;    Irradiation;    Heavy ion therapy;    Ion beam therapy;    Pancoast tumor;    Superior sulcus tumors;   

Others  :  1161238
DOI  :  10.1186/s12885-015-1163-7

 received in 2014-10-01, accepted in 2015-03-05,  发布年份 2015

【 摘 要 】

Background

The standard trimodal treatment concept in locally advanced and non-metastasized non-small-cell superior sulcus tumors consists of a preoperative chemoradiation followed by surgical resection. High linear energy transfer (LET) radiation as, for example, C12 heavy-ion beam therapy theoretically offers biological advantages compared to high energy x-ray therapy as, for example, higher biological efficiency.

Methods/Design

In the present prospective, single-armed, open pilot study performed at the Heidelberg Ion-Beam Therapy Center (HIT) in Heidelberg, the radiation treatment within the standard trimodal concept will be exchanged against C12 heavy-ion beam treatment and apply 39GyE in 13 single fractions in combination with a chemotherapy consisting of cisplatin and vinorelbine (local standard). The primary endpoint is feasibility and safety measured by the incidence of NCI-CTCAE grade 3/4 toxicity and/or discontinuation due to any reason. Secondary endpoint is the degree of regression in the histological specimen. The main inclusion criteria are histologically confirmed non-small-cell superior sulcus tumor, nodal disease stage ≤ N2, Karnofsky performance score ≥70%, patient age between 18 and 75 years as well as written informed consent. The main exclusion criteria include medical contraindications against elements of the trimodal treatment concept, PET confirmed nodal disease stage N3, stage IV disease, prior thoracic irradiation and decompensated diseases of the lung, cardio-vascular system, metabolism, hematopoietic and coagulation system and renal function. Furthermore, patients with implanted active medical devices without certification for ion-beam therapy are not allowed to take part in the study. Trial registration number: DRKS00006323 (www.drks.de webcite).

【 授权许可】

   
2015 Hauswald et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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