PILOT OBSERVATIONAL STUDY OF NEOADJUVANT 5 x 5 RADIOTHERAPY FOLLOWED BY TRANSANAL ENDOSCOPIC MICROSURGERY FOR T1-T2 EXTRAPERITONEAL RECTAL CANCER WITH CURATIVE INTENT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- incidence of local and distant recurrence
研究概览
简要总结
Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant already for T1 invasive cancers with submucosa infiltration >1 mm it is our intention to investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined treatment in a case series comparing results of this pilot study to an historical series of patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no neoadjuvant therapy.
If equally effective, TEM offers a further reduction in invasiveness of treatment, which should correspond to a lower morbidity, mortality and a better quality of life.
详细描述
Study design: This is a single centre case series pilot study which oncologic results will be compared to historical data collected consisting of patients treated by anterior resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no neoadjuvant radiotherapy.
Study population: Patients with T1sm2-3 and T2, N0, G1-G2, located between 2 and 12 cm from the anal verge, in a health condition that permits general anesthesia.
Interventions: Neoadjuvant radiotherapy at a dose of 25 Gy (5 Gy per day for 5 consecutive days) is administered to the patient. Within 10 days after the end of radiotherapy TEM will be performed.
Primary Endpoint: incidence of recurrence at 36 months
Primary outcome measure (for non-inferiority):
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a large rectal sessile or flat lesion (type 0-Is, 0-II or 0-III according to the Paris Classification) with the largest diameter of 2 cm or larger11 (estimated by an opened resection snare).
- •lower and upper borders of the rectal neoplasm located between 2 and 12 cm from the anal verge, respectively.
- •Biopsies of the lesion showed neoplastic tissue adenocarcinoma G1-G2 on histopathological evaluation.
- •Endoscopic ultrasonography (EUS) of the rectal lesion confirmed invasion into the submucosal layer (uT1sm) >1 mm or the muscle layer (uT2) and ruled out the presence of lymph nodes >1 cm.
- •Pelvic Magnetic Resonance Imaging (MRI) (or Computer Tomography (CT) when MRI was contraindicated) ruled outlymph nodes >1 cm.
- •ASA (America Society of Anesthesiologists)- status I-III.
排除标准
- •previous anorectal surgery
研究组 & 干预措施
Early Rectal Cancer
patients with T1 - T2, N0, G1-2 rectal cancer
干预措施: SRT-TEM (Procedure)
Early Rectal Cancer
patients with T1 - T2, N0, G1-2 rectal cancer
干预措施: LRT-TEM (Procedure)
Early Rectal Cancer
patients with T1 - T2, N0, G1-2 rectal cancer
干预措施: Transanal Endoscopic Microsurgery (TEM) (Procedure)
Early Rectal Cancer
patients with T1 - T2, N0, G1-2 rectal cancer
干预措施: Total Mesorectal Excision (TME) (Procedure)
结局指标
主要结局
incidence of local and distant recurrence
时间窗: 36 months
次要结局
- morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention)(30 days)
- disease specific and general quality of life(30 days)
- anorectal function(3 months)
研究者
Alberto Arezzo
Assistant Professor of Surgery
European Association for Endoscopic Surgery