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ABCSG R07 Rectal Cancer Registry (ABCSG R07 RCR)

16 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

600

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Austria
    • State of Salzburg
      • Salzburg, State of Salzburg, Austria, 5020
        • LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
        • Contatto:
          • Lukas Weiss, MD, Prof.
          • Numero di telefono: 25804 +4357255
          • Email: lu.weiss@salk.at
        • Investigatore principale:
          • Lukas Weiss, MD, Prof.
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Kepler Universitätsklinikum Linz
        • Contatto:
        • Investigatore principale:
          • Gudrun Piringer, MD, MSc
      • Linz, Upper Austria, Austria, 4010
        • Ordensklinikum Linz - BHS
        • Contatto:
        • Investigatore principale:
          • Holger Rumpold, MD, Head

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Responses (clinical standard therapy)
Lasso di tempo: At the time of surgery
Recording of treatment responses according to clinical standard therapy.
At the time of surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of different TNT concepts used
Lasso di tempo: From therapy start to Surgery
Treatment details
From therapy start to Surgery
Proportion of participants using immunotherapy
Lasso di tempo: From therapy start to Surgery
From therapy start to Surgery
Proportion of participants using watch & wait therapy
Lasso di tempo: At surgery visit
At surgery visit
Proportion of the surgical techniques used
Lasso di tempo: At surgery
At surgery
Proportion of locoregional recurrences
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline
Baseline
ECOG performance status at diagnosis
Lasso di tempo: Diagnosis
Diagnosis
Proportion of resection rates
Lasso di tempo: Surgery
Surgery
Treatment adherence
Lasso di tempo: From therapy start until surgery
From therapy start until surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaboratori

GlaxoSmithKline

Investigatori

  • Cattedra di studio: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
  • Cattedra di studio: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
  • Cattedra di studio: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 febbraio 2033

Completamento dello studio (Stimato)

1 febbraio 2033

Date di iscrizione allo studio

Primo inviato

19 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2026

Primo Inserito (Effettivo)

21 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ABCSG R07

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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