Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- pathologic complete response (pCR) rate
研究概览
简要总结
Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.
- •If there is more than one, classify as a high risk group Positive CRM threatening: 5mm ≦ Extramural depth Positive EMVI.
- •cN2: Positive Lateral pelvic LN metastasis
- •Between 19 and 80 years of age;
- •Satisfactory performance status: ECOG≦2
- •American Society of Anesthesiologists (ASA) physical status classification system class I~III
- •Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L;
- •Adequate renal function: creatinine ≤ 1.5×upper normal limit
排除标准
- •The evidence of relapse of distant metastasis
- •Receiving treatment of other anti-cancer drug or methods
- •Patients have low compliance and are not able to complete the entire trial
- •Presence of uncontrolled life-threatening diseases
- •cT4 with infiltration of anterior organ on pretreatment MRI
- •cT4 with infiltration of internal or external anal sphincter on pretreatment MRI
研究组 & 干预措施
Preoperative short-course radiotherapy
1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME)
干预措施: preoperative short-course radiotherapy (Radiation)
结局指标
主要结局
pathologic complete response (pCR) rate
时间窗: Two weeks after surgery
According to pathological response criteria, a total regression is considered a complete response
次要结局
- Incidence of acute toxicities during radiation and chemotherapy(Three months)
- Incidence of surgical complications(Four weeks after surgery)
- Quality of life(Baseline and QOL at 8 weeks after radiotherapy)
- Cost effectiveness(Three months)