van Broekhoven Danique L M, Grünhagenl Dirk J, van Dalen Thijs, van Coevorden Frits, Bonenkamp Han J, Been Lukas B, Bemelmans Marc H A, Dijkstra Sander D S, Colombo Chiara, Gronchi Alessandro, Verhoef Cornelis
Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Cancer. 2016 Aug 26;16(1):686. doi: 10.1186/s12885-016-2704-4.
The efficacy of the classical treatment modalities surgery and radiotherapy in the treatment of aggressive fibromatosis is presently disputed and there is a shift towards a more conservative approach. The aim of the present study is to objectify tumor growth in patients with extra-abdominal or abdominal wall aggressive fibromatosis, while adhering to a "watchful waiting" policy. Other objectives are to investigate quality of life and to identify factors associated with tumor growth, in particular the relation with the presence of a CTNNB1-gene mutation in the tumor.
GRAFITI is a nationwide, multicenter, prospective registration trial. All patients with extra-abdominal or abdominal wall aggressive fibromatosis are eligible for inclusion in the study. Main exclusion criteria are: history of familiar adenomatous polyposis, severe pain, functional impairment, life/limb threating situations in case of progressive disease. Patients included in the study will be treated with a watchful waiting policy during a period of 5 years. Imaging studies with ultrasound and magnetic resonance imaging scan will be performed during follow-up to monitor possible growth: the first years every 3 months, the second year twice and the yearly. In addition patients will be asked to complete a quality of life questionnaire on specific follow-up moments. The primary endpoint is the rate of progression per year, defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Secondary endpoints are quality of life and the rate of influence on tumor progression for several factors, such as CTNNB1-mutations, age and localization.
This study will provide insight in tumor behavior, the effect on quality of life and clinicopathological factors predictive of tumor progression.
The GRAFITI trial is registered in the Netherlands National Trial Register (NTR), number 4714 .
经典治疗方式（手术和放疗）在侵袭性纤维瘤病治疗中的疗效目前存在争议，且正朝着更保守的方法转变。本研究的目的是在坚持“观察等待”策略的同时，客观评估腹外或腹壁侵袭性纤维瘤病患者的肿瘤生长情况。其他目的是调查生活质量，并确定与肿瘤生长相关的因素，特别是与肿瘤中CTNNB1基因突变存在情况的关系。
GRAFITI是一项全国性、多中心、前瞻性注册试验。所有腹外或腹壁侵袭性纤维瘤病患者均符合纳入本研究的条件。主要排除标准为：家族性腺瘤性息肉病病史、严重疼痛、功能障碍、疾病进展时危及生命/肢体的情况。纳入研究的患者将在5年期间接受观察等待策略治疗。随访期间将进行超声和磁共振成像扫描等影像学检查，以监测可能的肿瘤生长：最初几年每3个月进行一次，第二年进行两次，之后每年进行一次。此外，还将要求患者在特定随访时间完成一份生活质量问卷。主要终点是每年的进展率，由实体瘤疗效评价标准（RECIST）定义。次要终点是生活质量以及几个因素（如CTNNB1突变、年龄和部位）对肿瘤进展的影响率。
本研究将深入了解肿瘤行为、对生活质量的影响以及预测肿瘤进展的临床病理因素。
GRAFITI试验已在荷兰国家试验注册中心（NTR）注册，注册号为4714。
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