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ABCSG R07 Rectal Cancer Registry (ABCSG R07 RCR)

2026年9月16日 更新者：Austrian Breast & Colorectal Cancer Study Group

ABCSG R07 Rectal Cancer Registry (RCR) - Multicenter Retrospective and Prospective Analysis of Patients With Localized, Non-metastatic Rectal Cancer in Austria

In Austria, patients with rectal cancer that has not spread to other parts of the body are typically treated with either total neoadjuvant therapy (TNT) or immunotherapy, depending on their microsatellite status (DNA repair capacity).

However, treatment can vary considerably between hospitals in Austria. These differences may include the type and duration of treatment, as well as the active ingredients used. There are currently no clear recommendations on which exact treatment is best for each specific case.

The aim of this observational study is to collect information on the different treatments used in Austria for patients with localized rectal cancer and to document the outcomes of these treatments.

Only information and samples collected as part of the patients' routine care will be used for the study. Participation in the study will not change or affect the treatment chosen by the treating physician.

研究概览

地位

尚未招聘

条件

详细说明

The purpose of this observational study is to establish a registry for locally advanced rectal adenocarcinoma. This registry will document the treatment regimens of participants receiving "total neoadjuvant therapy (TNT)" as well as those with dMMR/MSI-H disease.

The ABCSG R07 Rectal Cancer Registry (RCR) study will provide real-world data that reflect the current therapeutic landscape for participants. Participants who are either treated with "total neoadjuvant therapy (TNT)" or those with dMMR/ MSI-H disease, as well as their response to the respective standard therapy, will be documented.

"Total neoadjuvant therapy (TNT)" is the preferred treatment option for locally advanced rectal adenocarcinoma; however, treatment is carried out according to a different TNT protocol at each hospital or institute.

Since the observational study does not interfere with the course of treatment, neither additional health risks nor any individual benefit from participation in the non-interventional study is to be expected.

This study is being conducted at approx. 6 study sites in Austria, and a total of about 600 participants (retrospective and prospective) will take part. The treating physician selects the treatment/therapy that she/he considers most appropriate for the participant. In the retrospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between June 2020 (or June 2005 for dMMR/MSI-H cohort,) and start of this non-interventional study will be enrolled.

In the prospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between start of this non-interventional study and three years thereafter will be enrolled.

研究类型

观察性的

注册 (估计的)

600

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 奥地利
    • State of Salzburg
      • Salzburg、State of Salzburg、奥地利、5020
        • LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
        • 接触：
          • Lukas Weiss, MD, Prof.
          • 电话号码：25804 +4357255
          • 邮箱：lu.weiss@salk.at
        • 首席研究员：
          • Lukas Weiss, MD, Prof.
    • Upper Austria
      • Linz、Upper Austria、奥地利、4020
        • Kepler Universitätsklinikum Linz
        • 接触：
        • 首席研究员：
          • Gudrun Piringer, MD, MSc
      • Linz、Upper Austria、奥地利、4010
        • Ordensklinikum Linz - BHS
        • 接触：
        • 首席研究员：
          • Holger Rumpold, MD, Head

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status

描述

Inclusion Criteria:

  • Female and male participants with age >= 18 years
  • Signed informed consent obtained prior to registration of the participant.
  • Localized rectal cancer treated with TNT or localized, non-metastatic dMMR/MSI-H rectal cancer, irrespective of treatment

Exclusion Criteria:

  • Distant metastases at primary diagnosis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Retrospective part
Participants treated between June 2020 and study start. For dMMR/MSI-H cohort: treated between June 2005 until study start
Prospective part
Participants treated between study start and three years after study start

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment Responses (clinical standard therapy)
大体时间：At the time of surgery
Recording of treatment responses according to clinical standard therapy.
At the time of surgery

次要结果测量

结果测量
措施说明
大体时间
Proportion of different TNT concepts used
大体时间：From therapy start to Surgery
Treatment details
From therapy start to Surgery
Proportion of participants using immunotherapy
大体时间：From therapy start to Surgery
From therapy start to Surgery
Proportion of participants using watch & wait therapy
大体时间：At surgery visit
At surgery visit
Proportion of the surgical techniques used
大体时间：At surgery
At surgery
Proportion of locoregional recurrences
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
From therapy start until 3 years from re-staging or end of primary treatment
Proportion of the participants with distant metastases
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
From therapy start until 3 years from re-staging or end of primary treatment
Event-free survival (EFS)
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
EFS includes locoregional event, distant metastasis and death
From therapy start until 3 years from re-staging or end of primary treatment
TME-free survival in watch & wait group
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
From therapy start until 3 years from re-staging or end of primary treatment
Overall survival (OS)
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
From therapy start until 3 years from re-staging or end of primary treatment
Locoregional event-free survival (LREFS)
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
locoregional progression, recurrence, regrowth or death
From therapy start until 3 years from re-staging or end of primary treatment
Distant metastasis-free survival (DMFS)
大体时间：From therapy start until 3 years from re-staging or end of primary treatment
From therapy start until 3 years from re-staging or end of primary treatment
Charlson Comorbidity Index (CCI) Score prior to any treatment start
大体时间：Baseline
Baseline
ECOG performance status at diagnosis
大体时间：Diagnosis
Diagnosis
Proportion of resection rates
大体时间：Surgery
Surgery
Treatment adherence
大体时间：From therapy start until surgery
From therapy start until surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Austrian Breast & Colorectal Cancer Study Group

合作者

GlaxoSmithKline

调查人员

  • 学习椅：Falk Roeder, Prof, MD、Paracelsius Medical University Salzburg
  • 学习椅：Gudrun Piringer, MD, MSc、Johannes Kepler University Linz
  • 学习椅：Lukas Weiss, Prof, MD、Paracelsius Medical University Salzburg

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2033年2月1日

研究完成 (估计的)

2033年2月1日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ABCSG R07

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Key-coded personal information from this study may also be used for future ((non-)commercial, (inter-)national) scientific research projects & statistics, provided the respective project is conducted in compliance with accepted standards of ethical principles; the responsible researcher(s)/statistician(s) has/have no legal means to de-identify any key-coded personal information.

Data will be shared with other collaborating academic groups/people & companies who work with the Sponsors, including but not limited to ECs, ABCSG (holder of clin. database) and will be used for study purposes mentioned in protocol & future scientific research projects, if agreed by the participant.

Any data transfer will comply with respective applicable data law/regulations. The use of data must be defined in advance in a project description & SAP, approved by ABCSG Board/Committee and will be transferred acc. with resp. Data Transfer Agreement.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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