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NCT Number: NCT07780305

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.

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Key information

Conditions

Rectal Cancer Adenocarcinoma Adenocarcinoma of Rectum Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Rectal Neoplasms Turcot syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Salzburg-PMU, Univ. Klinik f. Innere Med III, Salzburg, State of Salzburg, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Treatment Responses (clinical standard therapy)

    Time frame: At the time of surgery

    Recording of treatment responses according to clinical standard therapy.

Secondary outcomes

  1. Proportion of different TNT concepts used

    Time frame: From therapy start to Surgery

    Treatment details

  2. Proportion of participants using immunotherapy

    Time frame: From therapy start to Surgery

  3. Proportion of participants using watch & wait therapy

    Time frame: At surgery visit

  4. Proportion of the surgical techniques used

    Time frame: At surgery

  5. Proportion of locoregional recurrences

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

  6. Proportion of the participants with distant metastases

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

  7. Event-free survival (EFS)

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

    EFS includes locoregional event, distant metastasis and death

  8. TME-free survival in watch & wait group

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

  9. Overall survival (OS)

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

  10. Locoregional event-free survival (LREFS)

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

    locoregional progression, recurrence, regrowth or death

  11. Distant metastasis-free survival (DMFS)

    Time frame: From therapy start until 3 years from re-staging or end of primary treatment

  12. Charlson Comorbidity Index (CCI) Score prior to any treatment start

    Time frame: Baseline

  13. ECOG performance status at diagnosis

    Time frame: Diagnosis

  14. Proportion of resection rates

    Time frame: Surgery

  15. Treatment adherence

    Time frame: From therapy start until surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Muehlburger, MSc

CONTACT

[email protected]

+43 1 4089230

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: ABCSG R07 RCR

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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