Rectal Cancer
Conditions
Brief summary
In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.
Interventions
DRUGCapecitabine
comparison of two treatments
Sponsors
Institute of Oncology Ljubljana
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven locally advanced rectal cancer and * the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.
Exclusion criteria
* distant metastases, * concomitant malignancy, * inflammatory bowel disease, or * malabsorption syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response | during surgery | pathological complete response is defined as the absence of tumor cells in the surgical resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neoadjuvant rectal cancer score | during treatment, assessed up to 10 days | Neoadjuvant rectal cancer score: The NAR score was calculated using the equation \[5 pN - 3(cT - pT) + 12\]\^2 / 9.61 and further classified as low (\< 8), intermediate (8-16), or high (\< 16). |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of participants who completed treatment | during treatment, assessed up to 10 days | Compliance - number of participants who completed treatment protocol |
| number of participants with acute side effects | during treatment, assessed up to 10 days | Acute toxcity - number of participants with side effects during different treatment modality |
Outcome results
None listed