ABCSG R07 Rectal Cancer Registry (ABCSG R07 RCR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; Adenocarcinoma of Rectum

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Miriam Muehlburger, MSc; Phone Number: +43 1 4089230; Email: miriam.muehlburger@abcsg.at

Study Locations

• Austria
  • State of Salzburg
    • Salzburg, State of Salzburg, Austria, 5020
      • LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
      • Contact: Lukas Weiss, MD, Prof.; Phone Number: 25804 +4357255; Email: lu.weiss@salk.at
      • Principal Investigator: Lukas Weiss, MD, Prof.
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler Universitätsklinikum Linz
      • Contact: Gudrun Piringer, MD, MSc; Phone Number: +435768082; Email: gudrun.piringer@kepleruniklinikum.at
      • Principal Investigator: Gudrun Piringer, MD, MSc
    • Linz, Upper Austria, Austria, 4010
      • Ordensklinikum Linz - BHS
      • Contact: Holger Rumpold, MD, Head; Phone Number: 4230 +43-732-7677; Email: holger.rumpold@bhs.at
      • Principal Investigator: Holger Rumpold, MD, Head

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Responses (clinical standard therapy)	Recording of treatment responses according to clinical standard therapy.	At the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of different TNT concepts used	Treatment details	From therapy start to Surgery
Proportion of participants using immunotherapy		From therapy start to Surgery
Proportion of participants using watch & wait therapy		At surgery visit
Proportion of the surgical techniques used		At surgery
Proportion of locoregional recurrences		From therapy start until 3 years from re-staging or end of primary treatment
Proportion of the participants with distant metastases		From therapy start until 3 years from re-staging or end of primary treatment
Event-free survival (EFS)	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		From therapy start until 3 years from re-staging or end of primary treatment
Overall survival (OS)		From therapy start until 3 years from re-staging or end of primary treatment
Locoregional event-free survival (LREFS)	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)		From therapy start until 3 years from re-staging or end of primary treatment
Charlson Comorbidity Index (CCI) Score prior to any treatment start		Baseline
ECOG performance status at diagnosis		Diagnosis
Proportion of resection rates		Surgery
Treatment adherence		From therapy start until surgery

Collaborators and Investigators

• Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborators: GlaxoSmithKline
• Investigators: Study Chair: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg; Study Chair: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz; Study Chair: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: cancer; adenocarcinoma; Non-interventional study; registry; locally advanced rectal cancer; Rectal; total neoadjuvant therapy; mismatch repair-deficient
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms; Rectal Neoplasms; Adenocarcinoma; Turcot syndrome
• Other Study ID Numbers: ABCSG R07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No