NCT02415101已完成不适用
Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Complete histological response proportion, using the Chirieac grading system.
研究概览
简要总结
This study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Histologically verified adenocarcinoma or SCC of the esophagus or GEJ Siewert type I and II.
- •Tumors should be resectable and without distant metastasis, as assessed after completed CRT.
- •Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
- •Pre CRT tumor stage: T1N1-3M0, T2N0-3M0, T3N0-3,M0, T4aN0-3,M0
- •Written informed consent
- •Completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant CRT schedule according to protocol within a period of <36 days.
排除标准
- •Concomitant malignant diagnosis (excluding non-melanoma skin cancer) <5 years since current cancer diagnosis.
- •Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy.
- •Patients being unable to comply with the protocol for reasons of language or cognitive function.
- •Tumor stage T1N0, T4bNX or TXNXM
- •Carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy.
- •Clear radiological signs of tumor progression during CRT on CT-scan after completion of CRT. PET is not used in this decision as FDG-activity often increase due to radiotherapy induced inflammation.
研究组 & 干预措施
Resective surgery after 4-6 weeks
Active Comparator
Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT)
干预措施: Resective surgery (Procedure)
Resective surgery after 10-12 weeks
Active Comparator
Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT)
干预措施: Resective surgery (Procedure)
结局指标
主要结局
Complete histological response proportion, using the Chirieac grading system.
时间窗: analysis is completed 4 weeks after surgery
次要结局
- Resectability rate in each study arm.(4-6 or 10-12 weeks after completed CRT)
- Safety and toxicity (only grade 3-5 toxicity will be reported) ety and toxicity (only grade 3-5 toxicity will be reported)(4-6 or 10-12 weeks after completed CRT)
- ypN tumor status, classified as ypN0 to ypN3.(analysis is completed 4 weeks after surgery)
- 5 year survival by intention to treat and per protocol analyses in each study arm.(5 years)
- QUALYs at 5 year follow-up in each study arm.(5 years after surgery)
- Overall primary tumor treatment response defined as complete histological response (Chirieac 0) and partial histological response (Chirieac 1 and 2) together.(analysis is completed 4 weeks after surgery)
- R0 resection rate in each study arm.(analysis is completed 4 weeks after surgery)
- Correlation between symptom scores, endoscopy and radiology; and complete histological response.(4 weeks after surgery)
- Nutritional status of patients in each study arm.(within a week before the start of CRT, within a week before surgery and 5 years after surgery)
- Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm.(5 years)
- Postoperative complications in each study arm.(30 days after surgery)
- Health-related quality of life (HRQOL).(4-6 or 10-12 weeks prior to surgery (at randomization after completed CRT), within a week before surgery, 6 months postoperatively, 12 months postoperatively and then yearly until 5 years of follow-up.)
研究者
Magnus Nilsson
Professor
Karolinska University Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal CancerNeoplasm, RectumNCT03287843Ege University350
Unknown
2 期
Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon CancerColon CancerNCT02882269The First Affiliated Hospital with Nanjing Medical University400
Unknown
3 期
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal CancerSquamous Cell Esophageal CarcinomaNCT01216527Sun Yat-sen University430
Unknown
不适用
Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer (CRONOS)Rectal CancerNeoadjuvant TherapyNCT04717947Hospital Clinic of Barcelona911
尚未招募
不适用
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk FactorsRadiotherapyNCT06566222Changhai Hospital2,000