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临床试验/NCT06839508
NCT06839508已完成不适用

Comprehensive Management of Rectal Cancer

Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
results heterogeneous.

研究概览

简要总结

study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Traditionally, for patients with mid or lower rectal cancer, a protocol involving chemoradiotherapy followed by surgery 8 to 10 weeks after the end of radiotherapy and chemotherapy is systematically indicated after a post-chemoradiotherapy reassessment using pelvic MRI.

In a certain number of patients (25%), it was noted that the reevaluation through pelvic MRI after chemoradiotherapy shows complete tumor disappearance.

However, these patients were still operated on according to the standard procedure, and pathologists found no tumor in the surgical specimen (sterile specimen).

These are patients with a complete radiological and pathological response. In such cases, it is possible to resect the scar that remains at the site of the tumor (radiotherapy sequelae) and closely monitor the patient to detect recurrence in the short and medium term, thus avoiding mutilating surgery that impacts quality of life (fecal and gas incontinence, increased bowel movements, urinary and gynecological sexual disorders). This is known as the "Watch and Wait" strategy.

"Watch and Wait" Strategy. An initial opportunistic approach, also called Watch and Wait (W&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al. in Brazil and published in 18 different articles, involving a cohort of 361 patients, with complete response rates ranging from 20% to 30%. Local recurrence rates varied from 5% to 25% depending on the articles and the timing of complete clinical response evaluation, while maintaining a 5-year disease-free survival rate of 52% and an overall survival rate of 85%. These series primarily included cT2 or cT3 tumors, but also cT4 tumors. Complete clinical response was defined as the absence of any clinical tumor residue (no tumor, no ulcer, and negative biopsy), and patients were monitored monthly.

However, the evaluation timeline for complete response varied across the articles, ranging from 8 weeks to 14 months.

At present, no official recommendations validate this strategy; it remains an expert opinion. The aim is to demonstrate that we could avoid surgery in patients with a complete response (we have favored rectal surgery for the majority of our patients due to organizational obstacles, patient-related issues, and the difficulty in applying rigorous surveillance in certain cases).

The purpose of this research is to improve our practices in managing rectal cancer in patients with a complete response.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
37 Years 至 98 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients managed in our facility who achieved a complete response after preoperative radio-chemotherapy.

排除标准

  • Minor patients
  • Non-responding patients, or partial responders.
  • Anal canal cancer

结局指标

主要结局

results heterogeneous.

时间窗: 10/05/2024

In all patients, a reevaluation was performed using a digital rectal exam (DRE), a rectosigmoidoscopy, a pelvic MRI, and a PET scan.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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