NL-OMON54095招募中3 期
Phase III study assessing the *best of* radiotherapy compared to the *best of* surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma - EORTC-1420 Best of Radiotherapy vs Best of Surgery
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •OPSCC in one of the following sub-sites: base of tongue, lateral pharyngeal
- •wall, tonsil, glosso-tonsillar sulcus, vallecula or SGSCC in one or more of the
- •following sub-sites: epiglottis, aryepiglottic fold, false cord or HPSCC in one
- •or more of the following subsites: Lateral and medial wall of piriform sinus
- •(sub-sites are defined as lateral (lateral pharyngeal wall, tonsil,
- •glosso-tonsillar sulcus, lateral wall of piriform sinus) vs. central lesions
- •(base of tongue, vallecula, all supraglottic sites, medial wall of piriform
- •TNM stage I-III (7th AJCC classification) for OPSCC and SGSCC: T1 or T2, N0
- •or T1 or T2, N1 with one single neck node <= 3cm without radiographic signs of
- •extracapsular extension (ECE), M0
- •TNM stage I for HPSCC: T1, N0, M0
- •Within 2 weeks before randomization, assessment by a Multi-Disciplinary Team
- •(MDT) composed of at least a head and neck/ENT surgeon, medical oncologist,
- •radiologist, radiotherapist, and pathologist of the treatment naïve patient and
- •suitable for either TOS or IMRT based on:
- •Contrast enhanced CT and/or MRI done within 4 weeks prior to randomization
- •Repeat contrast enhanced CT and/or MRI or US 1 week or less prior to
- •enrollment in case of suspicious nodes <1cm on initial scan if per local
- •Panendoscopy with assessment of trans-oral exposure for resection.
- •peri-nodal infiltration either via CT-scan or MRI.
- •ECOG Performance status <= 2;
- •Availability of biological material for HPV/p16 testing for OPSCCs
- •Age 18 and older; Age 18 to 70 for SGSCC
- •Study information and Informed consent discussed by the surgeon and
- •radio-oncologist and signed by the patient.
- •Within 2 weeks prior randomization:
- •Baseline MDADI score available;
- •Adequate bone marrow function as demonstrated by neutrophils count > 1,5 109
- •/L , platelets count > 75 109 /L, WBC>= 3.0 109 /L;
- •Prothrombin time (PT) with an international normalized ratio (INR) <= 1.2
- •Partial thromboplastin time (PTT) <= 1.2 times ULN
- •Women of child bearing potential (WOCBP) must have a negative serum or urine
- •pregnancy test no more than 72 hours prior to randomization.
- •Patients of childbearing / reproductive potential should agree to use
- •adequate birth control measures for 6 months, especially if they will undergo
- •any radiotherapy treatment at any time during the study. A highly effective
- •method of birth control is defined as those which result in low failure rate
- •(i.e. less than 1% per year) when used consistently and correctly.
排除标准
- •Any previous anti-cancer therapy for HNSCC (surgery, chemo, radiotherapy or
- •molecularly targeted therapy);
- •Any active malignancy (other than non-melanoma skin cancer or localized
- •cervical cancer or localized and presumed cured prostatic cancer) within the
- •last 5 years with ongoing systemic treatment
- •Cancer in contact with the internal and/or common carotid artery
- •Extension of OPSCC across the midline of the base-of-tongue
- •Arytenoid involvement in case of SGSCC
- •Infiltration of apex for piriform sinus in case of HPSCC
- •Cancer originating from the soft palate or posterior pharyngeal wall
- •Requirement of a reconstruction with a free or regional flap (i.e.
- •involvement of >50% of the soft palate)
- •Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic
- •Any psychological, cognitive, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol, completion
- •of patient reported measures and follow-up schedule; those conditions should be
- •discussed with the patient before registration in the trial
研究者
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