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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total neoadjuvant therapy | Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery. |
| |
| standard therapy | Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | comparison of two treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response | pathological complete response is defined as the absence of tumor cells in the surgical resection | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Neoadjuvant rectal cancer score | 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). | during treatment, assessed up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants who completed treatment | Compliance - number of participants who completed treatment protocol | during treatment, assessed up to 10 days |
| number of participants with acute side effects |
Inclusion Criteria:
Exclusion Criteria:
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all adult patients with newly diagnosed LARC with high risk factors for failure who were treated with TNT or standard therapy at the Institute of Oncology, Ljubljana, from 2016 to 2019
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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Acute toxcity - number of participants with side effects during different treatment modality
| during treatment, assessed up to 10 days |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |