跳至主要内容
临床试验/NCT00634777
NCT00634777Unknown不适用

Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
239
试验地点
2
主要终点
Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced

研究概览

简要总结

Patients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from organ-preservation treatment based on combination of chemotherapy and radiotherapy without compromising disease-free and overall survival. In patients with initially advanced regional disease, there is controversy about the place of routine planned lymph node neck dissection after chemoradiotherapy, especially in responding patients without clinically invaded residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small positive lymph nodes are not detected, and residual large lymph nodes can be sterilized ( " ghosts nodes " with no sign of viable tumor cells at histopathology). Despite the absence of evidence based on prospective study, in numerous institutions currently, head and neck surgeons are quite reluctant to operate on for neck dissection patients with a complete clinical and radiological response following chemoradiation.

Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head and neck SCC, especially after treatment to differentiate disease progression from radiation-induced inflammation.1 Several studies have shown that the metabolic response could predict the presence or absence of residual tumor cells in the primary tumor as well as the probability of relapse .2-4 Conflicting results have been reported on the use of PET to predict the pathological nodal status after chemoradiation, with negative predictive values ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was performed at variable time points after the end of radiotherapy. Ideally, PET should be performed as late as possible so that tumor regrowth can begin and become detectable, increasing the sensitivity of the procedure.

详细描述

- The primary objective is to assess the negative predictive value (NPV) of PET as a single examination in correctly predicting the absence of remaining invaded lymph nodes after chemoradiotherapy for advanced HNSCC.

Secondary objectives include :

  • The evaluation of the suitability of a wait and see approach without neck dissection in patients considered as complete responders ( based on clinical evaluation and imaging assessment including PET : all these diagnosis tools should be negative to consider a patient as a complete responder); this suitability will be estimated using the negative predictive value of the overall assessment of a complete response including PET-FDG but also the clinical evaluation and imaging.
  • The evaluation of the ability of PET-FDG to correctly predict remaining pathologically invaded lymph nodes (PPV) after chemoradiotherapy for advanced HNSCC in patients with a postchemoradiation positive PET a (and who will therefore be considered with less than a complete regional or locoregional response and who will undergo at least neck dissection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy-proven HNSCC
  • Clinical stage: unpreviously treated T1-T4 oral cavity, oropharynx, hypopharynx, larynx
  • Only patients suitable for at least a neck dissection after chemoradiotherapy will be included. Consequently, inclusion criteria are thus : T1-T4 , N1 N2a, N2b N2c N3 M
  • Patient scheduled for an organ preservation treatment protocol based on concomitant chemoradiation (induction chemotherapy is allowed if this approach is followed by concomitant chemoradiation)

排除标准

  • 未提供

结局指标

主要结局

Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced

时间窗: 12 weeks after chemoradiation

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other

研究点 (2)

Loading locations...

相似试验