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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Miriam Muehlburger, MSc
- Numéro de téléphone: +43 1 4089230
- E-mail: miriam.muehlburger@abcsg.at
Lieux d'étude
-
-
State of Salzburg
-
Salzburg, State of Salzburg, L'Autriche, 5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
-
Contact:
- Lukas Weiss, MD, Prof.
- Numéro de téléphone: 25804 +4357255
- E-mail: lu.weiss@salk.at
-
Chercheur principal:
- Lukas Weiss, MD, Prof.
-
-
Upper Austria
-
Linz, Upper Austria, L'Autriche, 4020
- Kepler Universitätsklinikum Linz
-
Contact:
- Gudrun Piringer, MD, MSc
- Numéro de téléphone: +435768082
- E-mail: gudrun.piringer@kepleruniklinikum.at
-
Chercheur principal:
- Gudrun Piringer, MD, MSc
-
Linz, Upper Austria, L'Autriche, 4010
- Ordensklinikum Linz - BHS
-
Contact:
- Holger Rumpold, MD, Head
- Numéro de téléphone: 4230 +43-732-7677
- E-mail: holger.rumpold@bhs.at
-
Chercheur principal:
- Holger Rumpold, MD, Head
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Responses (clinical standard therapy)
Délai: At the time of surgery
|
Recording of treatment responses according to clinical standard therapy.
|
At the time of surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of different TNT concepts used
Délai: From therapy start to Surgery
|
Treatment details
|
From therapy start to Surgery
|
|
Proportion of participants using immunotherapy
Délai: From therapy start to Surgery
|
From therapy start to Surgery
|
|
|
Proportion of participants using watch & wait therapy
Délai: At surgery visit
|
At surgery visit
|
|
|
Proportion of the surgical techniques used
Délai: At surgery
|
At surgery
|
|
|
Proportion of locoregional recurrences
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline
|
Baseline
|
|
|
ECOG performance status at diagnosis
Délai: Diagnosis
|
Diagnosis
|
|
|
Proportion of resection rates
Délai: Surgery
|
Surgery
|
|
|
Treatment adherence
Délai: From therapy start until surgery
|
From therapy start until surgery
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
- Chaise d'étude: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
- Chaise d'étude: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Maladies intestinales
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs colorectales
- Tumeurs intestinales
- Maladies rectales
- Tumeurs, glandulaires et épithéliales
- Carcinome
- Tumeurs
- Tumeurs rectales
- Adénocarcinome
- Syndrome de Turcot
Autres numéros d'identification d'étude
- ABCSG R07
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .