SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 188
- 试验地点
- 18
- 主要终点
- Disease-free survival
研究概览
简要总结
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.
The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.
Evaluation of the response 5 to 6 weeks after the RCT.
Step 2: Randomisation in patients with a complete clinical response:
Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence
Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically
- •Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation
- •Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting
- •Age ≥ 18 years < 75 years
- •Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.
排除标准
- •Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)
- •Weight loss > 15% at the recruitment with no improvement after nutritional support
- •Serious comorbidity threatening survival in the short term
- •Contra-indication for radiochemotherapy
- •Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)
- •Absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women
- •Impossibility to follow the trial
- •Legal disqualification (patients in custody or under guardianship)
研究组 & 干预措施
Arm A: Systematic surgery
干预措施: Systematic surgery (Other)
Arm B: Surveillance and rescue surgery in cases of resectable
干预措施: Surveillance and rescue surgery in cases of resectable loco-regional recurrence (Other)
结局指标
主要结局
Disease-free survival
时间窗: Up to 5 years
Proportion of surviving patients
时间窗: 1 year after randomisation
次要结局
未报告次要终点