Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Sustained clinical complete response at 1 year
研究概览
简要总结
This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.
详细描述
Background and Rationale
Standard treatment for early-stage rectal cancer is total mesorectal excision (TME), which provides good oncologic control but may result in substantial functional morbidity. Even in early tumors, radical surgery can lead to bowel dysfunction (including low anterior resection syndrome), urinary and sexual dysfunction, and in some cases permanent stoma formation. While oncologic outcomes are generally favorable, the long-term impact on quality of life remains significant for many patients.
Neoadjuvant chemoradiotherapy (CRT) has been shown to induce tumor regression in rectal cancer, and in a subset of patients a clinical complete response (cCR) may be achieved. In such cases, surgery may potentially be deferred under strict surveillance protocols, a strategy often referred to as organ preservation or "watch and wait." Previous prospective and international studies, including STAR-TREC, have demonstrated promising rates of clinical complete response in selected patients with early rectal tumors.
Study Objectives
Primary Objective To determine whether mesorectal chemoradiotherapy (50 Gy in 25 fractions combined with capecitabine 825 mg/m² twice daily on radiotherapy days) can achieve a sustained clinical complete response at one year in patients with early rectal cancer, allowing surgery to be safely deferred.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Written informed consent
- •Biopsy-proven rectal adenocarcinoma
- •Tumor located <12 cm from the anal verge
- •MRI-staged T1-T3b tumor
- •N0 or NX (no radiologic evidence of nodal metastases)
- •M0 or MX (no radiological evidence of distant metastases)
- •ECOG performance status 0-1
- •Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options
排除标准
- •MRI-defined N1 or higher nodal disease
- •Distant metastases (M1)
- •MRI extramural vascular invasion (mriEMVI)
- •Threatened mesorectal fascia (≤1 mm on MRI)
- •Maximum tumor diameter > 40 mm
- •MRI defined mucinous tumor
- •No residual luminal tumor following prior endoscopic resection
- •Recurrent rectal cancer
- •Prior pelvic radiotherapy
- •Uncontrolled significant cardiorespiratory comorbidity
- •Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- •Known Gilbert's syndrome
- •Pregnancy or breastfeeding
- •Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
- •Age <18 years
研究组 & 干预措施
Mesorectal chemoradiotherapy
Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care.
干预措施: Capecitabine + Radiotherapy (Combination Product)
Standard Surgery (Total Mesorectal Excision)
Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm.
干预措施: Total Mesorectal Excision (TME) (Procedure)
结局指标
主要结局
Sustained clinical complete response at 1 year
时间窗: 1 year
Proportion of participants in the organ preservation arm who achieve a clinical complete response (cCR) and remain without surgical resection at 1 year after initiation of treatment. Clinical complete response is defined by absence of residual tumor on MRI, no visible tumor on endoscopy (scar/fibrosis permitted), and no palpable tumor on clinical examination.
次要结局
- Clinical Complete Response at 3 Years(3 years)
- Local Recurrence Rate(3 years)
- Distant metastases(3 years)
- Overall Survival(up to 5 years)
- Organ Preservation Rate(3 years)
- Surgical Morbidity(Within 90 days after surgery)
- Total Length of Hospital Stay(Within 1 year after diagnosis)
- Patient reported quality of life(up to 3 years)
- Bowel function(Up to 3 years)