An observational study in Rectal Cancer and Adenocarcinoma of Rectum, sponsored by Austrian Breast & Colorectal Cancer Study Group. Recruiting at 6 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Austrian Breast & Colorectal Cancer Study Group · Observational
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.
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.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 600 is above the median of 161 across 498 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Austrian Breast & Colorectal Cancer Study Group is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants treated between June 2020 and study start. For dMMR/MSI-H cohort: treated between June 2005 until study start
Participants treated between study start and three years after study start
Treatment Responses (clinical standard therapy)
Recording of treatment responses according to clinical standard therapy.
Time frame: At the time of surgery
Proportion of different TNT concepts used
Treatment details
Time frame: From therapy start to Surgery
Proportion of participants using immunotherapy
Time frame: From therapy start to Surgery
Proportion of participants using watch & wait therapy
Time frame: At surgery visit
Proportion of the surgical techniques used
Time frame: At surgery
Proportion of locoregional recurrences
Time frame: From therapy start until 3 years from re-staging or end of primary treatment
Proportion of the participants with distant metastases
Time frame: 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
Time frame: From therapy start until 3 years from re-staging or end of primary treatment
TME-free survival in watch & wait group
Time frame: From therapy start until 3 years from re-staging or end of primary treatment
Overall survival (OS)
Time frame: 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
Time frame: From therapy start until 3 years from re-staging or end of primary treatment
Distant metastasis-free survival (DMFS)
Time frame: From therapy start until 3 years from re-staging or end of primary treatment
Charlson Comorbidity Index (CCI) Score prior to any treatment start
Time frame: Baseline
ECOG performance status at diagnosis
Time frame: Diagnosis
Proportion of resection rates
Time frame: Surgery
Treatment adherence
Time frame: From therapy start until surgery
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2033, 76 months after the start.
Of 213 non-industry observational studies under Rectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 76 months is above that.
Counting every sponsor, half of 228 studies reached it within 45 months; a quarter within 24 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Austrian Breast & Colorectal Cancer Study Group