2024-512526-28-00招募中3 期
Multicentre, open-label, randomized, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer (PelvEx II)
Catharina Ziekenhuis Stichting33 个研究点 分布在 5 个国家目标入组 364 人开始时间: 2024年4月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 364
- 试验地点
- 33
- 主要终点
- The rate of clear resection margins after surgery
研究概览
简要总结
To compare the rate of resections with clear resection margins between both arms.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal cancer or distal sigmoidal cancer, either by; histopathology ór; clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
- •Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy. Expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards are considered not resectable.
- •WHO performance score 0-1
- •Written informed consent
排除标准
- •Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion.
- •Homozygous DPD deficiency (if known in advance)
- •Any chemotherapy in the past 6 months.
- •Radiotherapy in the past 6 months for primary rectal cancer.
- •Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist.
- •Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist.
- •Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
- •Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
结局指标
主要结局
The rate of clear resection margins after surgery
The rate of clear resection margins after surgery
次要结局
- Progression free survival
- Distant metastasis free survival
- Local re-recurrence free survival
- Disease free survival
- Overall survival
- Pathologic response
- Radiological response
- Systemic therapy related toxicity (NCI-CTCAE v5.0 grade ≥3)
- The number of patients completing neoadjuvant treatment
- Surgical characteristics
- Major postoperative complications (Clavien-Dindo ≥3) up to 90-days postoperatively
- Quality of life
- Cost-effectiveness
研究者
Davy Creemers
Scientific
Catharina Ziekenhuis Stichting
研究点 (33)
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