Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Organ-preservation rate
研究概览
简要总结
The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are:
- What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX?
- Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤85 years
- •ECOG Performance status 0-1
- •Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
- •The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
- •Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
- •The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
- •No evidence of distant metastases
- •No prior pelvic radiation therapy
- •No prior chemotherapy or surgery for rectal cancer
- •No active infections requiring systemic antibiotic treatment
- •ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
- •Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
排除标准
- •Recurrent rectal cancer
- •Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
- •Creatinine level greater than 1.5 times the upper limit of normal
- •Patients who have received prior pelvic radiotherapy
- •Patients who are unable to undergo an MRI
- •Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS >5 years
- •Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
- •Other anticancer or experimental therapy
- •Women who are pregnant or breast-feeding
- •Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
研究组 & 干预措施
Group A: Nonoperative Management
Patients who achieve Clinical complete response (cCR) or near-cCR when restaged at 16 weeks following IMRT plus consolidation CapeOX.
干预措施: Nonoperative Management (NOM) (Procedure)
Group B: Local Excision
Patients with near-cCR or residual tumor ≤ycT2N0 when reassessed at 16 weeks following IMRT plus consolidation CapeOX; or Patients with regrowth ≤ycT2N0 when reassessed during surveillance in NOM;
干预措施: Local Excision (LE) (Procedure)
Group C: Total Mesorectal Excision
Patients with residual tumor >ycT2N0 when restaged at 16 weeks following IMRT plus consolidation CapeOX.
or Patients with regrowth >ycT2N0 when reassessed during surveillance in NOM; or Patients with any high-risk pathological factors following local excision (LE)
干预措施: Total Mesorectal Excision (TME) (Procedure)
结局指标
主要结局
Organ-preservation rate
时间窗: Three years
The rate of organ preservation will be defined as the percentage of patients who achieve cCR or near-cCR after neoadjuvant treatment followed by local excision or non-operative management (NOM). The time of organ preservation will be measured from the initiation of treatment.
次要结局
- Stoma-free survival(Three years)
- Rate of non-regrowth disease-free survival (NR-DFS)(Three years)
- Major adverse events(Three years)
研究者
Lin Wang
Unit III & Ostomy Service, Gastrointestinal Cancer Center
Peking University Cancer Hospital & Institute