Rectal CancerABCSG R07 RCRNCT07780305
ABCSG R07 Rectal Cancer Registry
An observational study of Rectal Cancer and Adenocarcinoma of Rectum, run by Austrian Breast & Colorectal Cancer Study Group at 3 sites in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma of Rectum
- How many people
- 600 participants
- Where
- 3 sitesAustria
- Study dates
- 1 Sep 2026to 1 Feb 2033
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status
Who may be able to join
- 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
Who cannot join
- Distant metastases at primary diagnosis
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria3 sites
Ordensklinikum Linz - BHS
Linz, Upper Austria, 4010
Holger Rumpold, MD, Head, +43-732-7677 ext. 4230, holger.rumpold@bhs.at
Holger Rumpold, MD, Head
Kepler Universitätsklinikum Linz
Linz, Upper Austria, 4020
Gudrun Piringer, MD, MSc, +435768082, gudrun.piringer@kepleruniklinikum.at
Gudrun Piringer, MD, MSc
LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
Salzburg, State of Salzburg, 5020
Lukas Weiss, MD, Prof., +4357255 ext. 25804, lu.weiss@salk.at
Lukas Weiss, MD, Prof.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Rectal Cancer, Adenocarcinoma of Rectum
- Keywords
- Rectal, cancer, registry, total neoadjuvant therapy, mismatch repair-deficient, locally advanced rectal cancer, Non-interventional study, adenocarcinoma
- Medical subject headings
- Rectal Neoplasms, Neoplasms, Turcot syndrome, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Treatment Responses (clinical standard therapy)
Recording of treatment responses according to clinical standard therapy.
Measured: At the time of surgery
Secondary outcomes (15)
Proportion of different TNT concepts used
Treatment details
Measured: From therapy start to Surgery
Proportion of participants using immunotherapy
Measured: From therapy start to Surgery
Proportion of participants using watch & wait therapy
Measured: At surgery visit
Proportion of the surgical techniques used
Measured: At surgery
Proportion of locoregional recurrences
Measured: From therapy start until 3 years from re-staging or end of primary treatment
Proportion of the participants with distant metastases
Measured: 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
Measured: From therapy start until 3 years from re-staging or end of primary treatment
TME-free survival in watch & wait group
Measured: From therapy start until 3 years from re-staging or end of primary treatment
Overall survival (OS)
Measured: 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
Measured: From therapy start until 3 years from re-staging or end of primary treatment
Distant metastasis-free survival (DMFS)
Measured: From therapy start until 3 years from re-staging or end of primary treatment
Charlson Comorbidity Index (CCI) Score prior to any treatment start
Measured: Baseline
ECOG performance status at diagnosis
Measured: Diagnosis
Proportion of resection rates
Measured: Surgery
Treatment adherence
Measured: From therapy start until surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2033 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Falk Roeder, Prof, MD, Study chair, Paracelsius Medical University SalzburgGudrun Piringer, MD, MSc, Study chair, Johannes Kepler University LinzLukas Weiss, Prof, MD, Study chair, Paracelsius Medical University Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780305
- Sponsor's protocol ID
- ABCSG R07
- Acronym
- ABCSG R07 RCR
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCSG R07 Rectal Cancer Registry (RCR) - Multicenter Retrospective and Prospective Analysis of Patients With Localized, Non-metastatic Rectal Cancer in Austria
- ClinicalTrials.gov ID
- NCT07780305
- Acronym / sponsor ID
- ABCSG R07 RCR / ABCSG R07
- Conditions
- Rectal Cancer, Adenocarcinoma of Rectum
- Keywords
- Rectal, cancer, registry, total neoadjuvant therapy, mismatch repair-deficient, locally advanced rectal cancer, Non-interventional study, adenocarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2033 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Distant metastases at primary diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Responses (clinical standard therapy)
Time frame: At the time of surgery
Recording of treatment responses according to clinical standard therapy.
15 secondary outcomes
Proportion of different TNT concepts used
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Falk Roeder, Prof, MD study chair
Paracelsius Medical University Salzburg
Gudrun Piringer, MD, MSc study chair
Johannes Kepler University Linz
Lukas Weiss, Prof, MD study chair
Paracelsius Medical University Salzburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Adenocarcinoma of Rectum, run by Austrian Breast & Colorectal Cancer Study Group at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Muehlburger, MSc (+43 1 4089230, miriam.muehlburger@abcsg.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Responses (clinical standard therapy) (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.