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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Miriam Muehlburger, MSc
- Número de teléfono: +43 1 4089230
- Correo electrónico: miriam.muehlburger@abcsg.at
Ubicaciones de estudio
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State of Salzburg
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Salzburg, State of Salzburg, Austria, 5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
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Contacto:
- Lukas Weiss, MD, Prof.
- Número de teléfono: 25804 +4357255
- Correo electrónico: lu.weiss@salk.at
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Investigador principal:
- Lukas Weiss, MD, Prof.
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Kepler Universitätsklinikum Linz
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Contacto:
- Gudrun Piringer, MD, MSc
- Número de teléfono: +435768082
- Correo electrónico: gudrun.piringer@kepleruniklinikum.at
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Investigador principal:
- Gudrun Piringer, MD, MSc
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Linz, Upper Austria, Austria, 4010
- Ordensklinikum Linz - BHS
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Contacto:
- Holger Rumpold, MD, Head
- Número de teléfono: 4230 +43-732-7677
- Correo electrónico: holger.rumpold@bhs.at
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Investigador principal:
- Holger Rumpold, MD, Head
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Retrospective part
Participants treated between June 2020 and study start.
For dMMR/MSI-H cohort: treated between June 2005 until study start
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Prospective part
Participants treated between study start and three years after study start
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment Responses (clinical standard therapy)
Periodo de tiempo: At the time of surgery
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Recording of treatment responses according to clinical standard therapy.
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At the time of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of different TNT concepts used
Periodo de tiempo: From therapy start to Surgery
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Treatment details
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From therapy start to Surgery
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Proportion of participants using immunotherapy
Periodo de tiempo: From therapy start to Surgery
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From therapy start to Surgery
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Proportion of participants using watch & wait therapy
Periodo de tiempo: At surgery visit
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At surgery visit
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Proportion of the surgical techniques used
Periodo de tiempo: At surgery
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At surgery
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Proportion of locoregional recurrences
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Proportion of the participants with distant metastases
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Event-free survival (EFS)
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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EFS includes locoregional event, distant metastasis and death
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From therapy start until 3 years from re-staging or end of primary treatment
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TME-free survival in watch & wait group
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Overall survival (OS)
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Locoregional event-free survival (LREFS)
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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locoregional progression, recurrence, regrowth or death
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From therapy start until 3 years from re-staging or end of primary treatment
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Distant metastasis-free survival (DMFS)
Periodo de tiempo: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Charlson Comorbidity Index (CCI) Score prior to any treatment start
Periodo de tiempo: Baseline
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Baseline
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ECOG performance status at diagnosis
Periodo de tiempo: Diagnosis
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Diagnosis
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Proportion of resection rates
Periodo de tiempo: Surgery
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Surgery
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Treatment adherence
Periodo de tiempo: From therapy start until surgery
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From therapy start until surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
- Silla de estudio: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
- Silla de estudio: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Enfermedades intestinales
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Neoplasias
- Neoplasias Rectales
- Adenocarcinoma
- Síndrome de turcot
Otros números de identificación del estudio
- ABCSG R07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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