Adenocarcinoma of Rectum, Rectal Cancer
Conditions
Keywords
Rectal, cancer, registry, total neoadjuvant therapy, mismatch repair-deficient, locally advanced rectal cancer, Non-interventional study, adenocarcinoma
Brief 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. 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.
Interventions
None listed
Sponsors
Austrian Breast & Colorectal Cancer Study Group
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Responses (clinical standard therapy) | At the time of surgery | Recording of treatment responses according to clinical standard therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of different TNT concepts used | From therapy start to Surgery | Treatment details |
| Proportion of participants using immunotherapy | From therapy start to Surgery | — |
| Proportion of participants using watch & wait therapy | At surgery visit | — |
| Proportion of the surgical techniques used | At surgery | — |
| Proportion of locoregional recurrences | From therapy start until 3 years from re-staging or end of primary treatment | — |
| Proportion of the participants with distant metastases | From therapy start until 3 years from re-staging or end of primary treatment | — |
| Event-free survival (EFS) | From therapy start until 3 years from re-staging or end of primary treatment | EFS includes locoregional event, distant metastasis and death |
| TME-free survival in watch & wait group | From therapy start until 3 years from re-staging or end of primary treatment | — |
| Overall survival (OS) | From therapy start until 3 years from re-staging or end of primary treatment | — |
| Locoregional event-free survival (LREFS) | From therapy start until 3 years from re-staging or end of primary treatment | locoregional progression, recurrence, regrowth or death |
| Distant metastasis-free survival (DMFS) | From therapy start until 3 years from re-staging or end of primary treatment | — |
| Charlson Comorbidity Index (CCI) Score prior to any treatment start | Baseline | — |
| ECOG performance status at diagnosis | Diagnosis | — |
| Proportion of resection rates | Surgery | — |
| Treatment adherence | From therapy start until surgery | — |
Countries
Austria
Contacts
CONTACTMiriam Muehlburger, MSc
STUDY_CHAIRFalk Roeder, Prof, MD
Paracelsius Medical University Salzburg
STUDY_CHAIRGudrun Piringer, MD, MSc
Johannes Kepler University Linz
STUDY_CHAIRLukas Weiss, Prof, MD
Paracelsius Medical University Salzburg
Outcome results
None listed